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Cognition, Flavonoids, Exercise, Gut Microbiome

Appalachian State University · NCT06495190

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 65–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
240
US sites recruiting
1
Study start
January 1, 2025
Record last updated
March 12, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Blueberry; Walking; Placebo; Stretching

Conditions: Cognitive Decline, Mild

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Appalachian State University Human Performance Lab, North Carolina Research Campus

    Kannapolis, NC 28081

    Site contact: David Nieman, DrPH · 828-773-0056 · niemandc@appstate.edu

Study contacts (from the official record)

  • David C Nieman, DrPH · 8287730056 · niemandc@appstate.edu
  • Camila A Olson, PhD · 7042505352 · olsonca1@appstate.edu
All healthy volunteers studies in North Carolina →
Cognition, Flavonoids, Exercise, Gut Microbiome (NCT06495190) | Bored Studies