Clinical trial · Interventional
Cognition, Flavonoids, Exercise, Gut Microbiome
Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Decline, Mild | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blueberry | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Stretching | Behavioral | — | UNRESOLVED |
| Walking | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Blueberry + walking
- description
- Blueberry intake combined with walking exercise.
- interventionNames
- Dietary Supplement: Blueberry
- Behavioral: Walking
- type
- EXPERIMENTAL
- label
- Blueberry + stretching
- description
- Blueberry intake combined with stretching exercise.
- interventionNames
- Dietary Supplement: Blueberry
- Behavioral: Stretching
- type
- ACTIVE_COMPARATOR
- label
- Placebo + walking
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available