search
Back to results

ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

Primary Purpose

Depressive Symptoms, Aging

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Freeze-dried Blueberry Powder
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depressive Symptoms

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women aged 65 years and older Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points) Exclusion Criteria: Unwilling to follow the study protocol Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19) Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions Self-reporting history of type 1 or type 2 diabetes Self-reporting any history of substance or alcohol use disorder Allergy to blueberries Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs Are excessive tea or coffee consumers (e.g., >3 cups/day) Recent and consistent use of antibiotics or pro-biotics Currently taking or advised during the intervention to take anti-depressants Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard Dose Freeze-dried Blueberry Powder

    Higher Dose Freeze-dried Blueberry Powder

    Arm Description

    Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.

    Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.

    Outcomes

    Primary Outcome Measures

    Urinary Flavonoid Biomarkers
    Change in total flavonoid metabolites found in the urine
    Inflammatory Biomarker C-reactive Protein
    Change in serum C-reactive Protein
    Inflammatory Biomarker interferon gamma
    Change in serum interferon gamma
    Inflammatory Biomarker interleukins 1B, 6, 8, 10
    Change in interleukins 1B, 6, 8, 10
    Inflammatory Biomarker tumor necrosis factor alpha
    Change in tumor necrosis factor alpha

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Hebrew SeniorLife
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05937165
    Brief Title
    ABSORB (Amount of Blueberries So Older Adults Reap Benefits)
    Official Title
    Acute Bioavailability of Berry Flavonoids and Impact on Inflammatory Biomarkers in Older Adults With Minor Depressive Symptoms: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    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 randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.
    Detailed Description
    Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 6 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Symptoms, Aging

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    6 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Dose Freeze-dried Blueberry Powder
    Arm Type
    Active Comparator
    Arm Description
    Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.
    Arm Title
    Higher Dose Freeze-dried Blueberry Powder
    Arm Type
    Experimental
    Arm Description
    Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.
    Intervention Type
    Other
    Intervention Name(s)
    Freeze-dried Blueberry Powder
    Intervention Description
    Three day consumption of two doses of freeze-dried blueberry powder
    Primary Outcome Measure Information:
    Title
    Urinary Flavonoid Biomarkers
    Description
    Change in total flavonoid metabolites found in the urine
    Time Frame
    3 days
    Title
    Inflammatory Biomarker C-reactive Protein
    Description
    Change in serum C-reactive Protein
    Time Frame
    3 days
    Title
    Inflammatory Biomarker interferon gamma
    Description
    Change in serum interferon gamma
    Time Frame
    3 days
    Title
    Inflammatory Biomarker interleukins 1B, 6, 8, 10
    Description
    Change in interleukins 1B, 6, 8, 10
    Time Frame
    3 days
    Title
    Inflammatory Biomarker tumor necrosis factor alpha
    Description
    Change in tumor necrosis factor alpha
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Men and women aged 65 years and older Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points) Exclusion Criteria: Unwilling to follow the study protocol Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19) Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions Self-reporting history of type 1 or type 2 diabetes Self-reporting any history of substance or alcohol use disorder Allergy to blueberries Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs Are excessive tea or coffee consumers (e.g., >3 cups/day) Recent and consistent use of antibiotics or pro-biotics Currently taking or advised during the intervention to take anti-depressants Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener

    12. IPD Sharing Statement

    Learn more about this trial

    ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

    We'll reach out to this number within 24 hrs