RECRUITING

Cognition, Flavonoids, Exercise, Gut Microbiome

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Conditions

Cognitive Decline, Mildagingflavonoidsexercisegut microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06495190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Healthy, non-smoking male or female participants 65 to 85 years of age.
  3. * Capable of engaging in a supervised 12-week exercise training program (brisk walking or stretching).
  4. * 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).
  5. * Willingness to be randomized to one of four groups.
  6. * Willingness to provide blood, urine, and fecal samples (3 each),
  7. * Willingness to avoid blueberry intake during the 12-weeks study (other than what is provided through the study).
  8. * 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.
  9. * Willingness to be a participant in this study only and not enter any other studies.
  1. * Allergy to blueberries.
  2. * Diagnosis of Type I or Type 2 diabetes.
  3. * Chronic cardiovascular, metabolic, or renal condition that is uncontrolled (controlled defined as stable for 6 months or more).
  4. * History of signs or symptoms during rest or physical activity such as chest discomfort, unreasonable breathlessness, dizziness, fainting, or blackouts.
  5. * Use of any prescription or over-the-counter drug intended to support cognition or with known cognitive side effects.
  6. * Any other concurrent condition or use of medications or supplements which, in the opinion of the study clinician would preclude participation in this study.
  7. * Diagnosis of dementia.

Contacts and Locations

Study Contact

David C Nieman, DrPH
CONTACT
8287730056
niemandc@appstate.edu
Camila A Olson, PhD
CONTACT
7042505352
olsonca1@appstate.edu

Principal Investigator

David C Nieman, DrPH
PRINCIPAL_INVESTIGATOR
Appalachian State Univ

Study Locations (Sites)

Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
United States

Collaborators and Investigators

Sponsor: Appalachian State University

  • David C Nieman, DrPH, PRINCIPAL_INVESTIGATOR, Appalachian State Univ

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • aging
  • flavonoids
  • exercise
  • gut microbiome

Additional Relevant MeSH Terms

  • Cognitive Decline, Mild