Actively Recruiting

Phase Not Applicable
Age: 65Years - 85Years
All Genders
Healthy Volunteers
NCT06495190

Cognition, Flavonoids, Exercise, Gut Microbiome

Led by Appalachian State University ยท Updated on 2025-03-12

240

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cognition, Flavonoids, Exercise, Gut Microbiome

Who Can Participate

Age: 65Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Score on the Montreal Cognitive Assessment (MoCA) between 24.1 and 25.2 indicating mild cognitive decline
  • Healthy, non-smoking male or female aged 65 to 85 years
  • Able to participate in a supervised 12-week exercise program (brisk walking or stretching)
  • Physically inactive (less than 150 minutes moderate or 75 minutes vigorous exercise per week in past 4 weeks)
  • Willing to be randomized into one of four study groups
  • Agree to provide blood, urine, and fecal samples
  • Willing to avoid eating blueberries outside of the study during the 12-week period
  • Willing to maintain current diet and physical activity levels during the study
  • Agree to participate only in this study and not join other studies concurrently
Not Eligible

You will not qualify if you...

  • Allergy to blueberries
  • Diagnosis of Type I or Type 2 diabetes
  • Uncontrolled chronic cardiovascular, metabolic, or kidney conditions (must be stable for at least 6 months)
  • History of chest discomfort, dizziness, fainting, or blackouts during rest or exercise
  • Use of prescription or over-the-counter drugs to support cognition or with cognitive side effects
  • Any condition or medication use judged by the study clinician to prevent participation
  • Diagnosis of dementia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, United States, 28081

Actively Recruiting

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Research Team

D

David C Nieman, DrPH

CONTACT

C

Camila A Olson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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