Back to resultsBlueberries, Inflammation, Motivation, and Physical Activity
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
Engagement in Physical Activity
Defined as median daily-step count over intervention
Secondary Outcome Measures
Study Recruitment Feasibility
Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm)
Motivation
Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation).
Inflammatory Marker - C-Reactive protein
Up to 12 weeks
Inflammatory Marker - Interleukin-6
Up to 12 weeks
Inflammatory Marker - Brain derived neurotrophic factor
Up to 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05735587
Brief Title
Blueberries, Inflammation, Motivation, and Physical Activity
Official Title
Dietary Intervention Targeting Inflammation, Motivation, and Engagement in Physical Activity in Sedentary, Older Adults With Depressive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 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
The purpose of this study is to determine the feasibility and preliminary efficacy of daily supplementation of freeze-dried blueberry to modulate inflammation-driven lack of motivation in 40 sedentary, older adults with depressive symptoms.
Detailed Description
The investigators will conduct a 14 week, single-site, randomized, double-blind, parallel pilot study in 40 sedentary, older adults with depressive symptoms. Participants will first enter a 2-week washout period where they will avoid consumption of foods high in fiber and anthocyanins (e.g., blueberries) and will also be wearing an activity monitor. 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 mood/well-being, relevant symptoms, motivation to engage in physical activity, and provide a blood sample for the evaluation of inflammatory biomarkers. For the entire duration of the study, participants will continue to wear the activity monitor. After 4, 6, 8 and 12 weeks of consuming the powder there will be study visits that assess mood/well-being, relevant symptoms, motivation to engage in physical activity and compliance with the intervention. Additionally, a blood sample for the evaluation of inflammatory makers will be taken after 6 and 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
Engagement in Physical Activity
Description
Defined as median daily-step count over intervention
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Study Recruitment Feasibility
Description
Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm)
Time Frame
Through study completion, approximately 6 months
Title
Motivation
Description
Motivation to engage in physical activity will be assessed via self-report questionnaire, Motives for Physical Activities Measure-Revised (range 0-30 points, with higher scores indicating higher levels of motivation).
Time Frame
Up to 12 weeks
Title
Inflammatory Marker - C-Reactive protein
Description
Up to 12 weeks
Time Frame
C-reactive protein (mg/dL) will be measured in blood collected from participants.
Title
Inflammatory Marker - Interleukin-6
Description
Up to 12 weeks
Time Frame
Interleukin-6 (pg/mL) will be measured in blood collected from participants.
Title
Inflammatory Marker - Brain derived neurotrophic factor
Description
Up to 12 weeks
Time Frame
Brain derived neurotrophic (pg/mL) factor will be measured in blood collected from participants.
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
Blueberries, Inflammation, Motivation, and Physical Activity
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