NCT07226674 · RECRUITING
Microbiota Mediated Flavonoid Metabolites for Cognitive Health
This study tests whether a plant-compound (polyphenol) supplement, compared with a placebo, changes gut bacteria byproducts and bile acids, and whether those changes relate to brain function and cognition. Adults 50 and older with a parent or sibling who had Alzheimer's take part. It has no phase label, so it is a mechanism study, not a test of a proven benefit.
You may qualify if
- 50+ years
- BMI ≥ 25 kg/m2
- Enhanced risk of AD - defined as family history of AD, 1st degree family member
- Habitually consume suboptimal diets such as typical Western diet (i.e., high in animal products, refined carbohydrates and processed food).
- Subjects capable of and willing to comply with the protocol and to give their written informed consent.
You're excluded if
- Cognitive impairment at 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) or Everyday Cognition Scale-12 (ECog-12, score\<1.36 included).
- Pre-existing psychosis or psychiatric conditions.
- Currently receiving treatment for dementia.
- History of substance abuse or cerebrovascular events.
- Heavy use of tobacco (>1/2 pack per day)
- Any intolerance or allergy documented or suspected to one of the components of the study products.
- Have taken probiotics or antibiotic therapy within the last 1 month
- Change in medication use in the last 3 months.
- Frailty, malnutrition, or food allergy/intolerance requiring special diets will also be excluded.
- Following any specific diet (vegetarian, vegan, etc.)
- Body weight at enrolment greater than 400lbs due to weight restrictions on the MRI table.
- Pregnant, breastfeeding, postpartum for less than 6 months, or unwilling to practice birth control during participation in the study.
- Unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, or metallic foreign body, etc.)
- Chronic pain.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Having a psychological or linguistic inability to sign the informed consent;
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- Subject participating in another biomedical study or participation in another study within the 3 months before entry into this study.
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 2025-11-24