NCT06507254 · RECRUITING
Polyphenols and Cognitive Decline
This trial is testing whether a daily polyphenol supplement, the kind of plant compounds found in berries, cocoa, and tea, can help protect cognitive function in older adults who are at higher risk for Alzheimer's disease. Researchers will track brain changes, gut microbiome shifts, and thinking ability over 12 months. This is a Phase NA randomized controlled trial, meaning it is a well-designed study but not a standard drug-approval phase.
Eligibility 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-31