Blueberries, Inflammation, Motivation, and Physical Activity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Intervention Targeting Inflammation, Motivation, and Engagement in Physical Activity in Sedentary, Older Adults With Depressive Symptoms

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Other: Freeze-dried Blueberry Powder
* Other: Placebo Powder


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freeze-dried Blueberry Powder<br>Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks. | Other: Freeze-dried Blueberry Powder<br>* 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.<br>|
| Placebo Comparator: Placebo Powder<br>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. | Other: Placebo Powder<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in Physical Activity | Defined as median daily-step count over intervention | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Recruitment Feasibility | Participant retention (e.g., the number of participants that complete the intervention out of all participants randomized to an intervention arm) | Through study completion, approximately 6 months | 
| 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). | Up to 12 weeks | 
| Inflammatory Marker - C-Reactive protein | Up to 12 weeks | C-reactive protein (mg/dL) will be measured in blood collected from participants. | 
| Inflammatory Marker - Interleukin-6 | Up to 12 weeks | Interleukin-6 (pg/mL) will be measured in blood collected from participants. | 
| Inflammatory Marker - Brain derived neurotrophic factor | Up to 12 weeks | Brain derived neurotrophic (pg/mL) factor will be measured in blood collected from participants. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anthocyanins, Fiber, Aging