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Completed

NCT Number: NCT05735587

Blueberries, Inflammation, Motivation, and Physical Activity

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Freeze-dried Blueberry Powder

Other

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.

Placebo Powder

Other

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 outcomes

  1. Change in Engagement in Physical Activity

    Time frame: Change between baseline and 12 week follow-up

    Defined as change between an approximate 2-week median daily-step count prior to baseline and prior to 12 week follow-up

Secondary outcomes

  1. Study Recruitment Feasibility

    Time frame: 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)

  2. Change in Motivation

    Time frame: Change between baseline and 12 week follow-up

    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).

  3. Change in Inflammatory Marker - C-Reactive Protein

    Time frame: Change between Baseline and 12 week follow-up.

    C-reactive protein (mg/L) will be measured in blood collected from participants.

  4. Change in Inflammatory Marker - Interleukin-6

    Time frame: Change between Baseline and 12 week follow-up

    Interleukin-6 (pg/mL) will be measured in blood collected from participants. If values were above the standard curve in the ELISA kit (n= 2 samples), then the highest standard concentration was used as the value.

  5. Change in Inflammatory Marker - Brain Derived Neurotrophic Factor

    Time frame: Change between Baseline and 12 week follow-up

    Brain derived neurotrophic (ng/mL) factor will be measured in blood collected from participants.

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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