Status:
RECRUITING
Cognition, Flavonoids, Exercise, Gut Microbiome
Lead Sponsor:
Appalachian State University
Conditions:
Cognitive Decline, Mild
Eligibility:
All Genders
65-85 years
Phase:
NA
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 popul...
Detailed Description
This randomized clinical trial (RCT) is designed to investigate the effect of 12-weeks blueberry ingestion (50 g freeze dried powder per day, equivalent to 2 cups fresh blueberries per day) with or wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06495190
Start Date
January 1 2025
End Date
December 31 2028
Last Update
March 12 2025
Active Locations (1)
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1
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28081