BridgeMD
New treatment option for Cognitive Decline, Mild
Official title Cognition, Flavonoids, Exercise, Gut Microbiome
ClinicalTrials.gov ID: NCT06495190
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 85. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- Willingness to be assigned by chance to one of four groups.
You likely can't join 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...
- 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...
See the full eligibility 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 assigned by chance 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kannapolis, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kannapolis, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.