Back to resultsEffect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
Primary Purpose
Depression, Depression, Anxiety, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze Dried Blueberry Powder - 71717
USHBC Blueberry Placebo Formula #114
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, inflammation, anxiety, blueberries
Eligibility Criteria
Inclusion Criteria:
- Participants with a stable diagnosis of Major Depressive Disorder (>1 year prior to enrollment)
- Males and females 18-70 years of age
- Subjects with sleep disruptions
- Subjects currently prescribed to a non-antipsychotic mono-pharmacotherapies
- English speaking subjects only (all evaluations are in English)
Subjects with the following inflammatory disorders that exhibit low to moderate symptoms:
- Hypertension (mild=140/80-160/90; moderate= 160/90-180/100)
- Asthma (requiring 2 or fewer inhalations of rescue inhaler per day)
- Gastroesophageal reflux disease
- Irritable bowel syndrome (controlled, <3 bowel movements a day)
- Arthritis (controlled)
- Chronic stomach ulcers (controlled)
- Obesity BMI <40
- Chronic pain
- Fibromyalgia
- Chronic Fatigue Syndrome
- Type I or Type II diabetes (controlled)
- Subjects that are compliant with current treatment regimens and clinic appointments
- Subjects taking intermittent or infrequent doses of acetaminophen or NSAIDs
- Subjects who currently smoke or have a history of smoking
Exclusion Criteria:
Subjects with current diagnosis or history of the following conditions; or subjects currently on medication for any of the following conditions:
- Severe Cardiovascular disease; Heart attack/pacemaker
- Cancer
- Autoimmunity Disorders
- Crohn's Disease or Ulcerative Colitis
- Alzheimer's Disease
- Parkinson's Disease
- Multiple Sclerosis
- Uncontrolled Diabetes: Type I or II
- Severe irritable bowel disease (>3 stools per day)
- Hypertension (severe >180/100)
- Hypotension (<100/60)
- Epilepsy
- Autism Spectrum Disorder
- Schizophrenia
- Psychosis/Psychotic Symptoms
- Uncontrolled Hypo/Hyperthyroidism
- Women who are pregnant, nursing, lactating, or planning to become pregnant within timeline of study
- Subjects who are blind or deaf
- Subjects who are allergic to blueberries or other similar foods or drinks (e.g. wine), or subjects who are allergic to red or blue food dye agents
- Subjects who do not like the taste of blueberries
- Subjects who do not want to disclose information related to their Major Depressive Disorder
- Subjects who do not want to be subjected to blood draws
- Subjects who consume >4 cups of blueberries per week or other foods/drinks with significant polyphenol content
- Subjects supplementing with elderberry syrup >4 times per week
- Subjects who have a planned surgery during the timeline of the study
- Subjects prescribed to antipsychotics
- Subjects using acetaminophen or NSAIDS (drugs targeting pro-inflammatory paths) chronically or exceeding recommended daily doses
- Subjects chronically on Decadron, Dexamethasone, or Prednisone; or other oral steroids
- Subjects on any augmenting agents (the following is not an inclusive list):
Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Clozaril(clozapine), Symbyax (olanzapine/fluoxetine), Geodon (ziprasidone)
- Subjects supplementing with devil's claw, fenugreek, guar gum, Panax ginseng, and Siberian ginseng
- Subjects who have a history of suicidal ideation or suicide attempt
- Subjects with a history or record of physical violence toward self or others
- Subjects who will jeopardize their job if they miss work for appointments
- Subjects with a history of addiction, except cigarettes
Sites / Locations
- Cottonport Family Clinic
- Marksville Family Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1-Blueberry First/Placebo First
2-Crossover
Arm Description
Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.
Participants who received blueberry treatment will switch to placebo and vice versa.
Outcomes
Primary Outcome Measures
Major Depression Inventory (MDI)
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI)
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI)
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI)
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI)
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Major Depression Inventory (MDI)
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time, and 5=all the time; the higher the score, the more severe the depressive symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Secondary Outcome Measures
C-Reactive Protein (CRP) Measure
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure
Biological measure of C-Reactive Protein from participant blood sample
CRP Measure
Biological measure of C-Reactive Protein from participant blood sample
Gut Microbiome Analysis
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Gut Microbiome Analysis
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Leeds Sleep Evaluation Questionnaire (LSEQ)
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ)
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ)
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ)
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ)
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Leeds Sleep Evaluation Questionnaire (LSEQ)
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Concentration of reactive oxygen species (ROS)
Electron paramagnetic resonance (EPR) to measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS)
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS)
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS)
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS)
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of reactive oxygen species (ROS)
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Concentration of quinolinic acid
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of quinolinic acid
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Concentration of kynurenic acid
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenic acid
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Concentration of kynurenine
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of kynurenine
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Concentration of tryptophan
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of tryptophan
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO)
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO)
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO)
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO)
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO)
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration of indoleamine 2,3-dioxygenase (IDO)
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2)
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein SKA-2
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1)
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein SAT-1
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4)
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of suicide-associated protein SLC4A4
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Concentration of brain-derived neurotropic factor (BDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of brain-derived neurotropic factor (BDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of glial cell line-derived neurotropic factor (GDNF)
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Concentration of serotonin related compound serotonin transporter (SERT)
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound SERT
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA)
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of serotonin related compound 5-HIAA
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Concentration of glutamate
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamate
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Concentration of glutamine
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of glutamine
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Concentration of cortisol
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of cortisol
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6)
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6)
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6)
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6)
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6)
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 6 (IL-6)
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Full Information
NCT ID
NCT04398784
First Posted
March 29, 2020
Last Updated
May 18, 2020
Sponsor
Louisiana State University, Baton Rouge
Collaborators
U.S. Highbush Blueberry Council, Louisiana Health Care Practitioners, LLC, Collective Healthcare Solutions, LLC, uBiome, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04398784
Brief Title
Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
Official Title
Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University, Baton Rouge
Collaborators
U.S. Highbush Blueberry Council, Louisiana Health Care Practitioners, LLC, Collective Healthcare Solutions, LLC, uBiome, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study aims to measure the effects of an intervention of 22.5 grams of freeze-dried whole blueberry powder in water drunk daily. Measures are on outcomes of depression, biological markers of inflammation and oxidative stress, and microbial populations in the intestines.
Detailed Description
A 29 week double-blind, placebo-controlled, crossover intervention assessing the effect of a blueberries on behavioral symptoms related to depression, biological markers of inflammation and oxidative stress, and gut microbiome measures. A total of 45 participants will be randomly assigned to either a blueberry-first or placebo-first group; participants will take 22.5 grams of either freeze-dried blueberry powder or matched placebo powder mixed with water daily for 12 weeks. This period is followed by a 4 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression, Anxiety, Inflammation
Keywords
depression, inflammation, anxiety, blueberries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study will utilize a randomized, double-blind, placebo-controlled, crossover design. 60 participants with depression will be randomized into either the placebo first or blueberry first group. Randomization will be based on outcomes from behavioral measures (Major Depression Inventory and GAD-7) and a physiological measure (C-reactive protein levels) in appointment 0. The first arm will consist of 12 weeks of daily treatment and baseline (pre-intervention), mid-intervention and post-intervention assessments. Next there will be a four week washout period, after which patients will switch treatments, and the second arm will commence--identical to the first in structure. Further, the study is a repeated measures design with each participant's baseline measures serving as her or his own control.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The blueberry treatment and placebo powders have been supplied by the U.S. Highbush Blueberry Council; packets are labeled either alpha or omega. The treatment powder is a freeze-dried whole blueberry powder, and the placebo is a color- and flavor-matched powder which has been used in previous trials. Only an unblinded research assistant will have knowledge of which label corresponds to blueberry or placebo. That research assistant will be in charge of: (1) Before each appointment, distributing appropriate treatment or placebo packets into closable boxes with a number corresponding to each participant. Care-providers will give closed boxes to participants at the time of assessment. (2) Re-labeling all collected data and samples with a participant code number, and sorting into appropriate groups for analysis by blinded researchers.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-Blueberry First/Placebo First
Arm Type
Other
Arm Description
Participants will be randomly assigned into either blueberry-first treatment or placebo-first group.
Arm Title
2-Crossover
Arm Type
Other
Arm Description
Participants who received blueberry treatment will switch to placebo and vice versa.
Intervention Type
Dietary Supplement
Intervention Name(s)
Freeze Dried Blueberry Powder - 71717
Other Intervention Name(s)
Tifblue/Rubel 50/50 Blend
Intervention Description
Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption.
Intervention Type
Dietary Supplement
Intervention Name(s)
USHBC Blueberry Placebo Formula #114
Intervention Description
Blueberry flavor- and color-matched placebo powder.
Primary Outcome Measure Information:
Title
Major Depression Inventory (MDI)
Description
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Major Depression Inventory (MDI)
Description
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Time Frame
Day 30 of treatment intervention
Title
Major Depression Inventory (MDI)
Description
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Time Frame
Day 60 of treatment intervention
Title
Major Depression Inventory (MDI)
Description
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Major Depression Inventory (MDI)
Description
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.
Time Frame
Day 30 of placebo intervention
Title
Major Depression Inventory (MDI)
Description
A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time, and 5=all the time; the higher the score, the more severe the depressive symptom.
Time Frame
Day 60 of placebo intervention
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Time Frame
Day 30 of treatment intervention
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Time Frame
Day 60 of treatment intervention
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Time Frame
Day 30 of placebo intervention
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.
Time Frame
Day 60 of placebo intervention
Title
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
Description
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
Description
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Time Frame
Day 60 of treatment intervention
Title
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
Description
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)
Description
A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.
Time Frame
Day 60 of placebo intervention
Secondary Outcome Measure Information:
Title
C-Reactive Protein (CRP) Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Immediately after enrollment, 30 days before start of intervention
Title
CRP Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
CRP Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Day 30 of treatment intervention
Title
CRP Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Day 60 of treatment intervention
Title
CRP Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
CRP Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Day 30 of placebo intervention
Title
CRP Measure
Description
Biological measure of C-Reactive Protein from participant blood sample
Time Frame
Day 60 of placebo intervention
Title
Gut Microbiome Analysis
Description
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Gut Microbiome Analysis
Description
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Time Frame
Day 30 of treatment intervention
Title
Gut Microbiome Analysis
Description
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Time Frame
Day 60 of treatment intervention
Title
Gut Microbiome Analysis
Description
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Gut Microbiome Analysis
Description
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Time Frame
Day 30 of placebo intervention
Title
Gut Microbiome Analysis
Description
uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome
Time Frame
Day 60 of placebo intervention
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Description
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Description
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Time Frame
Day 30 of treatment intervention
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Description
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Time Frame
Day 60 of treatment intervention
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Description
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Description
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Time Frame
Day 30 of placebo intervention
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Description
A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.
Time Frame
Day 60 of placebo intervention
Title
Concentration of reactive oxygen species (ROS)
Description
Electron paramagnetic resonance (EPR) to measures reactive oxygen species (ROS) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of reactive oxygen species (ROS)
Description
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of reactive oxygen species (ROS)
Description
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of reactive oxygen species (ROS)
Description
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of reactive oxygen species (ROS)
Description
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of reactive oxygen species (ROS)
Description
Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of quinolinic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of quinolinic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of quinolinic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of quinolinic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of quinolinic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of quinolinic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of kynurenic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of kynurenic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of kynurenic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of kynurenic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of kynurenic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of kynurenic acid
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of kynurenine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of kynurenine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of kynurenine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of kynurenine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of kynurenine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of kynurenine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of tryptophan
Description
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of tryptophan
Description
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of tryptophan
Description
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of tryptophan
Description
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of tryptophan
Description
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of tryptophan
Description
Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of indoleamine 2,3-dioxygenase (IDO)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of indoleamine 2,3-dioxygenase (IDO)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of indoleamine 2,3-dioxygenase (IDO)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of indoleamine 2,3-dioxygenase (IDO)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of indoleamine 2,3-dioxygenase (IDO)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of indoleamine 2,3-dioxygenase (IDO)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of suicide-associated protein SKA-2
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of suicide-associated protein SKA-2
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of suicide-associated protein SKA-2
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of suicide-associated protein SKA-2
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of suicide-associated protein SKA-2
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of suicide-associated protein SAT-1
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of suicide-associated protein SAT-1
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of suicide-associated protein SAT-1
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of suicide-associated protein SAT-1
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of suicide-associated protein SAT-1
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of suicide-associated protein SLC4A4
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of suicide-associated protein SLC4A4
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of suicide-associated protein SLC4A4
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of suicide-associated protein SLC4A4
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of suicide-associated protein SLC4A4
Description
Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of brain-derived neurotropic factor (BDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of brain-derived neurotropic factor (BDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of brain-derived neurotropic factor (BDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of brain-derived neurotropic factor (BDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of brain-derived neurotropic factor (BDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of brain-derived neurotropic factor (BDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of glial cell line-derived neurotropic factor (GDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of glial cell line-derived neurotropic factor (GDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of glial cell line-derived neurotropic factor (GDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of glial cell line-derived neurotropic factor (GDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Time Frame
Day 1 of placebo intervention, before placebo intervention
Title
Concentration of glial cell line-derived neurotropic factor (GDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of glial cell line-derived neurotropic factor (GDNF)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of serotonin related compound serotonin transporter (SERT)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of serotonin related compound SERT
Description
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of serotonin related compound SERT
Description
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of serotonin related compound SERT
Description
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of serotonin related compound SERT
Description
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of serotonin related compound SERT
Description
Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA)
Description
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of serotonin related compound 5-HIAA
Description
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of serotonin related compound 5-HIAA
Description
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of serotonin related compound 5-HIAA
Description
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of serotonin related compound 5-HIAA
Description
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of serotonin related compound 5-HIAA
Description
Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of glutamate
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of glutamate
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of glutamate
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of glutamate
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of glutamate
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of glutamate
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of glutamine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of glutamine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of glutamine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of glutamine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of glutamine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of glutamine
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of cortisol
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of cortisol
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of cortisol
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of cortisol
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of cortisol
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of cortisol
Description
Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of inflammation biomarker interleukin 6 (IL-6)
Description
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of inflammation biomarker interleukin 6 (IL-6)
Description
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of inflammation biomarker interleukin 6 (IL-6)
Description
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of inflammation biomarker interleukin 6 (IL-6)
Description
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of inflammation biomarker interleukin 6 (IL-6)
Description
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of inflammation biomarker interleukin 6 (IL-6)
Description
Luminex assay to measure interleukin 6 (IL-6) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Description
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Description
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Description
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Description
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Description
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)
Description
Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Description
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Description
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Description
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Description
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Description
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of inflammation biomarker interferon gamma (IFN-gamma)
Description
Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples
Time Frame
Day 60 of placebo intervention
Title
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Description
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Time Frame
Day 1 of treatment intervention, before treatment consumption
Title
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Description
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Time Frame
Day 30 of treatment intervention
Title
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Description
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Time Frame
Day 60 of treatment intervention
Title
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Description
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Time Frame
Day 1 of placebo intervention, before placebo consumption
Title
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Description
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Time Frame
Day 30 of placebo intervention
Title
Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)
Description
Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples
Time Frame
Day 60 of placebo intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with a stable diagnosis of Major Depressive Disorder (>1 year prior to enrollment)
Males and females 18-70 years of age
Subjects with sleep disruptions
Subjects currently prescribed to a non-antipsychotic mono-pharmacotherapies
English speaking subjects only (all evaluations are in English)
Subjects with the following inflammatory disorders that exhibit low to moderate symptoms:
Hypertension (mild=140/80-160/90; moderate= 160/90-180/100)
Asthma (requiring 2 or fewer inhalations of rescue inhaler per day)
Gastroesophageal reflux disease
Irritable bowel syndrome (controlled, <3 bowel movements a day)
Arthritis (controlled)
Chronic stomach ulcers (controlled)
Obesity BMI <40
Chronic pain
Fibromyalgia
Chronic Fatigue Syndrome
Type I or Type II diabetes (controlled)
Subjects that are compliant with current treatment regimens and clinic appointments
Subjects taking intermittent or infrequent doses of acetaminophen or NSAIDs
Subjects who currently smoke or have a history of smoking
Exclusion Criteria:
Subjects with current diagnosis or history of the following conditions; or subjects currently on medication for any of the following conditions:
Severe Cardiovascular disease; Heart attack/pacemaker
Cancer
Autoimmunity Disorders
Crohn's Disease or Ulcerative Colitis
Alzheimer's Disease
Parkinson's Disease
Multiple Sclerosis
Uncontrolled Diabetes: Type I or II
Severe irritable bowel disease (>3 stools per day)
Hypertension (severe >180/100)
Hypotension (<100/60)
Epilepsy
Autism Spectrum Disorder
Schizophrenia
Psychosis/Psychotic Symptoms
Uncontrolled Hypo/Hyperthyroidism
Women who are pregnant, nursing, lactating, or planning to become pregnant within timeline of study
Subjects who are blind or deaf
Subjects who are allergic to blueberries or other similar foods or drinks (e.g. wine), or subjects who are allergic to red or blue food dye agents
Subjects who do not like the taste of blueberries
Subjects who do not want to disclose information related to their Major Depressive Disorder
Subjects who do not want to be subjected to blood draws
Subjects who consume >4 cups of blueberries per week or other foods/drinks with significant polyphenol content
Subjects supplementing with elderberry syrup >4 times per week
Subjects who have a planned surgery during the timeline of the study
Subjects prescribed to antipsychotics
Subjects using acetaminophen or NSAIDS (drugs targeting pro-inflammatory paths) chronically or exceeding recommended daily doses
Subjects chronically on Decadron, Dexamethasone, or Prednisone; or other oral steroids
Subjects on any augmenting agents (the following is not an inclusive list):
Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Clozaril(clozapine), Symbyax (olanzapine/fluoxetine), Geodon (ziprasidone)
Subjects supplementing with devil's claw, fenugreek, guar gum, Panax ginseng, and Siberian ginseng
Subjects who have a history of suicidal ideation or suicide attempt
Subjects with a history or record of physical violence toward self or others
Subjects who will jeopardize their job if they miss work for appointments
Subjects with a history of addiction, except cigarettes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Francis, Ph.D.
Organizational Affiliation
Louisiana State University, Baton Rouge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cottonport Family Clinic
City
Cottonport
State/Province
Louisiana
ZIP/Postal Code
71327
Country
United States
Facility Name
Marksville Family Clinic
City
Marksville
State/Province
Louisiana
ZIP/Postal Code
71351
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population
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