NCT05735587

Blueberries, Inflammation, Motivation, and Physical Activity

Completed NA Results posted Last updated 30 July 2025

What this trial tests

NA trial testing Freeze-dried Blueberry Powder in Depressive Symptoms in 33 participants. Completed in 16 July 2024.

Timeline

5 April 2023

Primary endpoint
16 July 2024

16 July 2024

Quick facts

Lead sponsor	Hebrew SeniorLife
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	33
Start date	5 April 2023
Primary completion	16 July 2024
Estimated completion	16 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Freeze-dried Blueberry Powder
• Placebo Powder

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →

Sponsor

Hebrew SeniorLife — full company profile →

Who can join

65 and older, any sex, with Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Engagement in Physical Activity Primary · 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

Group	Value	95% CI
Freeze-dried Blueberry Powder	318	± 1778
Placebo Powder	346	± 624

Study Recruitment Feasibility Secondary · 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)

Group	Value	95% CI
Freeze-dried Blueberry Powder	12
Placebo Powder	10

Change in Motivation Secondary · 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).

Group	Value	95% CI
Freeze-dried Blueberry Powder	4	± 18
Placebo Powder	0	± 12

Change in Inflammatory Marker - C-Reactive Protein Secondary · Change between Baseline and 12 week follow-up.

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

Group	Value	95% CI
Freeze-dried Blueberry Powder	0.6	± 2.6
Placebo Powder	-1.6	± 4.9

Change in Inflammatory Marker - Interleukin-6 Secondary · 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.

Group	Value	95% CI
Freeze-dried Blueberry Powder	-0.5	± 1.2
Placebo Powder	-0.7	± 2.6

Change in Inflammatory Marker - Brain Derived Neurotrophic Factor Secondary · Change between Baseline and 12 week follow-up

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

Group	Value	95% CI
Freeze-dried Blueberry Powder	1.258	± 10.038
Placebo Powder	-1.226	± 12.116

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were captured throughout the study duration of each participant, which was approximately 14 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Freeze-dried Blueberry Powder

Serious: 0/15 (0%)

Deaths: 0/15

Placebo Powder

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (7 terms — click to expand)

Reaction	System	Freeze-dried Blueberry Pow…	Placebo Powder
Unpleasant taste and/or experience while taking study powder	Product Issues	—	—
Vomiting	Gastrointestinal disorders	—	—
Increased frequency of bowel movements	Gastrointestinal disorders	—	—
Muscle Pain	Musculoskeletal and connective tissue disorders	—	—
Bloating	Gastrointestinal disorders	—	—
High Blood Pressure	Cardiac disorders	—	—
Constipation	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT05735587 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of targeted web-based advertising versus traditional methods for recruiting older adults into clinical trials.
   Baldyga K, Iloputaife I, Taffet G, LaGanke N, et al · · 2025 · cited 1× · PMID 39412893 · DOI 10.1111/jgs.19225
2. 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.
   Millar CL, Wolfe A, Baldyga K, Dufour AB, et al · · 2025 · PMID 40442715 · DOI 10.1186/s12937-025-01154-0