Back to resultsBerries, Bugs, and the Blues
Primary Purpose
Depressive Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze-dried Blueberry Powder
Placebo Powder
Sponsored by
About this trial
This is an interventional other trial for Depressive Symptoms focused on measuring Anthocyanins, Fiber, Aging
Eligibility Criteria
Inclusion Criteria: Men and women aged ≥65 years Self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior) Depressive symptoms (defined as ≥4 and <16 points on the center for epidemiological studies depression-scale Exclusion Criteria: Unwilling to follow the study protocol A median daily step count >7,500 steps per day (as measured by the ActiGraph) Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA <22 points) Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders Self-reporting type 1 or type 2 diabetes Allergic to intervention or control products Recent use (within the last 3 months) of antibiotics Recent use (within the last 3 months) of pro-biotics Current substance use disorder (Drug Abuse Screening Test, DAST-10>2 points) Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C≥4 points) Unstable anti-depressant use (e.g., change in medication within last 3-6 months) Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener) Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ>12 points) Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ >5 points)
Sites / Locations
- Hebrew Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Freeze-dried Blueberry Powder
Placebo Powder
Arm Description
Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.
Randomized participants will be asked to consume 48 grams of a nutritionally matched placebo powder devoid of fiber and anthocyanins each day for 12 weeks.
Outcomes
Primary Outcome Measures
Depressive Symptom Severity
Severity of depressive symptoms will be measured each week with the Center for Epidemiological Studies Depression Scale (CES-D). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.
Secondary Outcome Measures
Abundance microbes
The abundance of microbes that produce short chain fatty acids(e.g., Bifidobacteria, Eubacterium, and Clostridium) will be evaluated by whole genome sequencing
Fecal short chain fatty acids
The concentration of short chain fatty acids in feces will be measured using gas chromatography mass spectrometry.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05817383
Brief Title
Berries, Bugs, and the Blues
Official Title
Blueberries, Gut Microbiota, and Metabolites in Depressed Older Adults - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew SeniorLife
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the impact of daily freeze-dried blueberry powder consumption on the gut microbiota, fecal short chain fatty acids, and depressive symptom severity in 40older, sedentary adults with depressive symptoms.
Detailed Description
This study is an ancillary project to a currently funded randomized, placebo-controlled 12-week intervention in older, sedentary adults with depressive symptoms (IRB# Pro00064749). This specific project proposes distinct aims to the trial by gathering preliminary data on the synergistic impact of dietary fiber and anthocyanins (via freeze-dried blueberry powder) on the gut-microbiota, gut-derived metabolites, and depressive symptoms in older adults.
Participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (~600 mg of anthocyanins and ~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks.
At baseline, participants will be undergo assessments for depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement. After 4, 8, and 12 weeks of consuming the powder there will be study visits that assess depressive symptom severity. Additionally, a final fecal sample will be taken after 12 weeks of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Anthocyanins, Fiber, Aging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Freeze-dried Blueberry Powder
Arm Type
Experimental
Arm Description
Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.
Arm Title
Placebo Powder
Arm Type
Placebo Comparator
Arm Description
Randomized participants will be asked to consume 48 grams of a nutritionally matched placebo powder devoid of fiber and anthocyanins each day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Freeze-dried Blueberry Powder
Intervention Description
Participants will be asked to consume 48 grams of freeze-dried blueberry powder (~ equivalent to 2 cups of fresh blueberries) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
Intervention Type
Other
Intervention Name(s)
Placebo Powder
Intervention Description
Participants will be asked to consume 48 grams of a nutritionally matched placebo powder (that does not contain fiber or anthocyanins) daily for 12 weeks. Participants will be asked to save any powder packet wrappers as a means to measure compliance. They will also be instructed to avoid consumption of foods/beverages that are high in anthocyanins and/or fiber.
Primary Outcome Measure Information:
Title
Depressive Symptom Severity
Description
Severity of depressive symptoms will be measured each week with the Center for Epidemiological Studies Depression Scale (CES-D). Scores range from 0 to 60 points, with higher scores indicating more sever depressive symptoms.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Abundance microbes
Description
The abundance of microbes that produce short chain fatty acids(e.g., Bifidobacteria, Eubacterium, and Clostridium) will be evaluated by whole genome sequencing
Time Frame
After 12 weeks
Title
Fecal short chain fatty acids
Description
The concentration of short chain fatty acids in feces will be measured using gas chromatography mass spectrometry.
Time Frame
After 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged ≥65 years
Self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior)
Depressive symptoms (defined as ≥4 and <16 points on the center for epidemiological studies depression-scale
Exclusion Criteria:
Unwilling to follow the study protocol
A median daily step count >7,500 steps per day (as measured by the ActiGraph)
Cognitive impairment (defined as Montreal Cognitive Assessment, MoCA <22 points)
Self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders
Self-reporting type 1 or type 2 diabetes
Allergic to intervention or control products
Recent use (within the last 3 months) of antibiotics
Recent use (within the last 3 months) of pro-biotics
Current substance use disorder (Drug Abuse Screening Test, DAST-10>2 points)
Current alcohol use disorder (Alcohol Use Disorders Identification Test - Consumption, AUDIT-C≥4 points)
Unstable anti-depressant use (e.g., change in medication within last 3-6 months)
Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener)
Current psychosis (via the Psychosis and Hallucinations Questionnaire, PHQ>12 points)
Manic symptoms (assessed by the Mood Disorder Questionnaire, MDQ >5 points)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Wolfe, MS
Phone
6179715674
Email
alexwolfe@hsl.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Baldyga, BA
Phone
6179715380
Email
kathrynbaldyga@hsl.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Millar, PhD
Organizational Affiliation
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew Rehabilitation Center
City
Roslindale
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Millar
Phone
617-971-5531
Email
courtneymillar@hsl.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Berries, Bugs, and the Blues
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