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Cognition, Flavonoids, Exercise, Gut Microbiome
Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome
Who can join
Ages 65 to 85 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
About the study
This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome.
What is being tested
- Blueberry (dietary supplement)
- Walking (behavioral)
- Placebo (dietary supplement)
- Stretching (behavioral)
Sponsor: Appalachian State University · Participants: 240 · Started: Jan 1, 2025
Contact the study team
- David C Nieman, DrPH · Phone: 8287730056
- Camila A Olson, PhD · Phone: 7042505352
Official record on ClinicalTrials.gov — NCT06495190
Locations in the U.S.
| North Carolina | Appalachian State University Human Performance Lab, North Carolina Research Campus, Kannapolis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.