RecruitingNot ApplicableNCT06495190

Cognition, Flavonoids, Exercise, Gut Microbiome

Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome


Sponsor

Appalachian State University

Enrollment

240 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 85 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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.

Interventions

DIETARY_SUPPLEMENTBlueberry

50 g/d blueberry powder supplement

BEHAVIORALWalking

Five 45-min walking sessions per week

DIETARY_SUPPLEMENTPlacebo

50 g/d placebo powder supplement

BEHAVIORALStretching

Five 45-min stretching sessions per week


Locations(1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, United States

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NCT06495190


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