Effects of blueberries and exercise on cognitive function in older adults
Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome
This study is testing whether eating blueberries and exercising can help older adults with mild memory problems think better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Appalachian State University Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (Kannapolis, North Carolina) |
| Trial ID | NCT06495190 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a 12-week regimen of blueberry intake combined with moderate exercise on cognitive function in older adults experiencing mild cognitive decline. Participants will be randomized into four groups: blueberry with walking, blueberry with stretching, placebo with walking, and placebo with stretching. The study aims to determine if the cognitive benefits are mediated by changes in the gut microbiome. Assessments will include cognitive tests and analysis of biological samples to evaluate the effects of the interventions.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-smoking adults aged 65 to 85 with mild cognitive decline.
Not a fit: Patients with severe cognitive impairment or those unable to participate in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and slow cognitive decline in older adults.
How similar studies have performed: Other studies have shown promising results with dietary interventions and exercise in improving cognitive function, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kannapolis, North Carolina
- Appalachian State University Human Performance Lab, North Carolina Research Campus — Kannapolis, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: David C Nieman, DrPH — Appalachian State Univ
- Study coordinator: David C Nieman, DrPH
- Email: niemandc@appstate.edu
- Phone: 8287730056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.