Effects of polyphenols on cognitive decline in older adults
MAEVE: Microbiota Mediated Flavonoid Metabolites for Cognitive Health
This study is testing if a supplement made from polyphenols, which are found in Mediterranean foods, can help older adults at risk for Alzheimer's disease keep their brains healthy and slow down cognitive decline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06507254 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential of polyphenols, found in a Mediterranean diet, to prevent or delay cognitive decline in older adults at risk for Alzheimer's disease. Participants aged 50 and older who are overweight or obese and consume a typical Western diet will be given either a polyphenol supplement or a placebo. The study aims to explore how these dietary interventions may influence brain health and gut microbiome interactions, potentially leading to improved cognitive function. By focusing on the role of gut-derived metabolites, the research seeks to uncover new strategies for healthy cognitive aging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 and older who are overweight or obese and at enhanced risk for Alzheimer's disease due to family history.
Not a fit: Patients who are vegan or vegetarian, have existing cognitive impairment, or are currently receiving treatment for dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention to help preserve cognitive function and reduce the risk of Alzheimer's disease in older adults.
How similar studies have performed: Other studies have shown promising results in using dietary interventions to improve cognitive health, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 50+ Years of age * Male or Female * At enhanced risk of Alzheimers Disease (defined as family history of AD, 1st degree family member) * Overweight or Obese (BMI≥25kg/m\^2) * Habitually consume suboptimal diets such as typical Western Diet (i.e., high in animal products, refined carbohydrates and processed food) * Able to communicate well in English Exclusion Criteria: * Vegan or Vegetarian * Presence of cognitive impairment at the time of recruitment into the study as measured by the Mini Mental Status Exam (MMSE, score 25-30) and Clinical Dementia Rating (CDR, score=0). * Pre-existing psychosis or psychiatric conditions * Currently receiving treatment for dementia * History of alcohol and/or substance abuse/dependence as determined by a positive endorsement on the MINI+/ If the MINI+ is positive for alcohol or drug dependence, or abuse, the participants will be excluded. * Heavy use of tobacco (greater than 1/2 pack per day) * History of cerebrovascular events * Existing allergies to berry fruits * Use of oral/IV antibiotics in the last 3 months. Use of probiotics in the last 1 month. * Recent Changes (last 3 months) in the use of psychoactive medications or other medications that interfere with the measured outcomes. * Frailty, malnutrition, or food allergy/intolerance requiring special diets. * Body weight at enrollment greater than 400lbs due to weight restrictions on the MRI table. * Women who are pregnant, lactating, or postpartum for less than 6months. * Women of childbearing age who are not practicing birth control or are planning to get pregnant during the study. Unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign body, etc.) * Chronic Pain
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Arpana Church, PhD — The Regents of the University of California, Los Angeles
- Study coordinator: Marika Dy, MPH
- Email: ChurchLab@mednet.ucla.edu
- Phone: 2670089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.