Recruiting

Observational Study

Sponsor:

Appalachian State University

Code:

NCT06495190

Conditions

Cognitive Decline, Mild

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Blueberry

Walking

Placebo

Stretching

Study Details

Brief 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.

Conditions

Cognitive Decline, Mild

Study ID

NCT06495190

Start date

Jan 1, 2025

Status verified date

Mar, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Blueberry + walking

Blueberry intake combined with walking exercise.

experimental: Blueberry + stretching

Blueberry intake combined with stretching exercise.

active comparator: Placebo + walking

Placebo intake combined with walking exercise.

active comparator: Placebo + stretching

Placebo intake combined with stretching exercise.

Interventions

Blueberry

50 g/d blueberry powder supplement

Walking

Five 45-min walking sessions per week

Placebo

50 g/d placebo powder supplement

Stretching

Five 45-min stretching sessions per week

Primary outcome measure

  • Cognition [ Time Frame: Change from pre-study to 6-weeks and 12-weeks ]

Central Contacts and Locations

Central contacts

David C Nieman, DrPH

8287730056niemandc@appstate.edu

Camila A Olson, PhD

7042505352olsonca1@appstate.edu

Locations

Appalachian State University Human Performance Lab, North Carolina Research Campus

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

David Nieman, DrPH

828-773-0056niemandc@appstate.edu

Camila A Sakaguchi, PhD

7042505352olsonca1@appstate.edu

Principal Investigator:

David Nieman, DrPH

More Information

Sponsor

Appalachian State University

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Keywords

  • aging
  • flavonoids
  • exercise
  • gut microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Appalachian State University on 2025-03-12.