NCT06495190 Cognition, Flavonoids, Exercise, Gut Microbiome
| NCT ID | NCT06495190 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Appalachian State University |
| Condition | Cognitive Decline, Mild |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
David C Nieman, DrPH
PRINCIPAL INVESTIGATOR
Appalachian State Univ
Frequently Asked Questions
Who can join the NCT06495190 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Cognitive Decline, Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06495190 currently recruiting?
Yes, NCT06495190 is actively recruiting participants. Contact the research team at niemandc@appstate.edu for enrollment information.
Where is the NCT06495190 trial being conducted?
This trial is being conducted at Kannapolis, United States.
Who is sponsoring the NCT06495190 clinical trial?
NCT06495190 is sponsored by Appalachian State University. The principal investigator is David C Nieman, DrPH at Appalachian State Univ. The trial plans to enroll 240 participants.