NCT06495190Recruiting
Cognition, Flavonoids, Exercise, Gut Microbiome
Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 3 Jul 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Appalachian State University
- NCT number
- NCT06495190
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 1 Jan 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Diagnosis of dementia.
Who the study is looking for
- 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.
Age in the registry: 65 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Appalachian State University Human Performance Lab, North Carolina Research Campus Coordinator of this site? Confirm its status | Kannapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.