Effects of blueberries and exercise on cognitive function in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of a 12-week regimen of blueberry intake combined with moderate exercise on cognitive function in older adults experiencing mild cognitive decline. Participants will be randomized into four groups: blueberry with walking, blueberry with stretching, placebo with walking, and placebo with stretching. The study aims to determine if the cognitive benefits are mediated by changes in the gut microbiome. Assessments will include cognitive tests and analysis of biological samples to evaluate the effects of the interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: David C Nieman, DrPH — Appalachian State Univ
• Study coordinator: David C Nieman, DrPH
• Email: niemandc@appstate.edu
• Phone: 8287730056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.