NCT06495190 · RECRUITING
Cognition, Flavonoids, Exercise, Gut Microbiome
This NIH-funded trial is testing whether eating blueberries daily for 12 weeks, combined with regular brisk walking, slows mild age-related cognitive decline in older adults. Researchers will also look at whether the gut microbiome plays a role in any benefit. It is a Phase N/A trial, meaning it is a behavioral and dietary intervention study, not a drug trial, and no FDA approval process applies.
You may qualify if
- Score on the Montreal Cognitive Assessment (MoCA test) of 24.1-25.2 that indicates mild cognitive decline. The MoCA test score ranges from 0 to 30, with higher scores from 26 to 30 considered normal.
- Healthy, non-smoking male or female participants 65 to 85 years of age.
- Capable of engaging in a supervised 12-week exercise training program (brisk walking or stretching).
- Physically inactive (defined as less than 150 min/week moderate or less than 75 minutes vigorous aerobic and/or resistance exercise during the past 4 weeks).
- Willingness to be randomized to one of four groups.
- Willingness to provide blood, urine, and fecal samples (3 each),
- Willingness to avoid blueberry intake during the 12-weeks study (other than what is provided through the study).
- Willingness to maintain current diet and physical activity patterns during the study (other than what is prescribed as a part of the study), and make no formal attempts to lose or gain body weight.
- Willingness to be a participant in this study only and not enter any other studies.
You're excluded if
- Allergy to blueberries.
- Diagnosis of Type I or Type 2 diabetes.
- Chronic cardiovascular, metabolic, or renal condition that is uncontrolled (controlled defined as stable for 6 months or more).
- History of signs or symptoms during rest or physical activity such as chest discomfort, unreasonable breathlessness, dizziness, fainting, or blackouts.
- Use of any prescription or over-the-counter drug intended to support cognition or with known cognitive side effects.
- Any other concurrent condition or use of medications or supplements which, in the opinion of the study clinician would preclude participation in this study.
- Diagnosis of dementia.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-03-12