Gut-derived flavonoid compounds to support thinking and memory

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes adults at elevated Alzheimer's risk to receive either a polyphenol supplement or a placebo and follows cognitive tests, blood metabolites, and gut microbiome measures. The approach aims to raise circulating phenyl-γ-valerolactones (PVLs), neuroprotective compounds produced by gut bacteria from flavan-3-ols. Eligible participants are age 50+, overweight (BMI ≥25), habitually eat a Western-style diet, and have normal cognition at entry; recent antibiotic or probiotic use and existing dementia are excluded. Primary outcomes link changes in microbial composition and PVL levels with cognitive performance and related biomarkers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Ulster University, Human Intervention Studies Unit
  Coleraine, United Kingdom Recruiting

Study contacts

• Principal investigator: Chris Gill, PhD — Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.
• Study coordinator: Chris Gill, PhD
• Email: c.gill@ulster.ac.uk
• Phone: +44 28 7012 3181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.