Cognition, Flavonoids, Exercise, Gut Microbiome
ConditionCognitive Decline, Mild
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorAppalachian State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Blueberry
Dietary supplement50 g/d blueberry powder supplement
Walking
BehavioralFive 45-min walking sessions per week
Placebo
Dietary supplement50 g/d placebo powder supplement
Stretching
BehavioralFive 45-min stretching sessions per week
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Blueberry + walkingExperimental treatment 2 interventions
Group B: Blueberry + stretchingExperimental treatment 2 interventions
Group C: Placebo + walkingActive comparator 2 interventions
Group D: Placebo + stretchingActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cognition
Cognitive function using the Cambridge Neuropsychological Test Assessment Battery (CANTAB, Cambridge Cognition, Ltd).
Time frame
Change from pre-study to 6-weeks and 12-weeksSecondary outcomes
1
Maximal aerobic capacity
VO2max from a graded treadmill test using a metabolic cart
Time frame
Change from pre-study to 6-weeks and 12-weeks2
Gut microbiome
Alpha and beta diversity from gut microbiome taxa analysis using Whole Genome Shotgun (WGS) sequencing
Time frame
Change from pre-study to 6-weeks and 12-weeks3
Urine blueberry metabolites
Urine gut-derived metabolites (n=24) from targeted LC-MS/MS analysis (concentrations) generated from blueberry ingestion
Time frame
Change from pre-study to 6-weeks and 12-weeks4
Electrophysiological procedures (ERP) using the Geodesic Sensor Net
An electroencephalogram (EEG) test that measures cognition from electrical activity (amplitude in microvolts) in the brain in response to cognitive challenges including working memory
Time frame
Change from pre-study to 6-weeks and 12-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov