Blueberries, Inflammation, Motivation, and Physical Activity

Not Applicable

Active, not recruiting

• Conditions: Depressive Symptoms
• Interventions: Other: Freeze-dried Blueberry Powder; Other: Placebo Powder

• Registration Number: NCT05735587
• Lead Sponsor: Hebrew SeniorLife

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.

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Study Start: 2023-04-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-02-28
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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), or per discretion of the PI
• 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, or per discretion of the PI
• Self-reporting type 1 or type 2 diabetes
• Allergic to intervention or control products
• Recent use (within the last 3 months) of antibiotics, or per discretion of the PI
• Recent use (within the last 3 months) of pro-biotics, or per discretion of the PI
• 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), or per discretion of the PI
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freeze-dried Blueberry Powder	Freeze-dried Blueberry Powder	Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.
Placebo Powder	Placebo Powder	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.

Primary Outcome Measures

Name	Time	Method
Engagement in Physical Activity	Up to 12 weeks	Defined as median daily-step count over intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hebrew Rehabilitation Center; 🇺🇸 Roslindale, Massachusetts, United States