Blueberries, Inflammation, Motivation, and Physical Activity

NCT ID: NCT05735587

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2024-07-16

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.

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Freeze-dried Blueberry Powder

Randomized participants will be asked to consume 48 grams of freeze-dried blueberry powder each day for 12 weeks.

Group Type: EXPERIMENTAL

Freeze-dried Blueberry Powder

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo Powder

Intervention Type: 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.

Interventions

Freeze-dried Blueberry Powder

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

Placebo Powder

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.

Intervention Type: OTHER

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), 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebrew SeniorLife

OTHER

Sponsor Role: lead

Responsible Party

Courtney Millar

Assistant Scientist I

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Courtney Millar, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical Schools

Locations

Hebrew Rehabilitation Center

Roslindale, Massachusetts, United States

Countries

United States

References

Millar CL, Wolfe A, Baldyga K, Dufour AB, Lipsitz LA. Berries and Steps: a protocol of a randomized, placebo-controlled pilot study testing freeze-dried blueberry powder in sedentary older adults with mild depressive symptoms. Nutr J. 2025 May 29;24(1):87. doi: 10.1186/s12937-025-01154-0.

Reference Type: DERIVED

PMID: 40442715 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00064749

Identifier Type: -

Identifier Source: org_study_id