Cognition, Flavonoids, Exercise, Gut Microbiome
Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 12, 2025
March 1, 2025
3 years
July 3, 2024
March 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognition
Cognitive function using the Cambridge Neuropsychological Test Assessment Battery (CANTAB, Cambridge Cognition, Ltd).
Change from pre-study to 6-weeks and 12-weeks
Secondary Outcomes (4)
Maximal aerobic capacity
Change from pre-study to 6-weeks and 12-weeks
Gut microbiome
Change from pre-study to 6-weeks and 12-weeks
Urine blueberry metabolites
Change from pre-study to 6-weeks and 12-weeks
Electrophysiological procedures (ERP) using the Geodesic Sensor Net
Change from pre-study to 6-weeks and 12-weeks
Study Arms (4)
Blueberry + walking
EXPERIMENTALBlueberry intake combined with walking exercise.
Blueberry + stretching
EXPERIMENTALBlueberry intake combined with stretching exercise.
Placebo + walking
ACTIVE COMPARATORPlacebo intake combined with walking exercise.
Placebo + stretching
ACTIVE COMPARATORPlacebo intake combined with stretching exercise.
Interventions
50 g/d blueberry powder supplement
Five 45-min walking sessions per week
Five 45-min stretching sessions per week
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David C Nieman, DrPH
Appalachian State Univ
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Investigators and study participants will be blind to treatment allocation, with the blueberry and placebo supplements administered in identical packets.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 10, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When the study is completed in 2028 and will be available for five years afterwards.
- Access Criteria
- Researchers with relevant expertise and a track record in the research area related to the IPD can request access. Researchers must submit a research proposal outlining their research goals, analysis plan, and how the IPD will be used.
Upon reasonable request.