Microbiota Mediated Flavonoid Metabolites for Cognitive Health
NCT ID: NCT07226674
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-10
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Polyphenol Supplement
Juice Plus Essentials, Berry Blend Capsules
Polyphenol Supplement
Juice Plus Essentials, Berry Blend Capsules
Placebo Supplement
Placebo Supplement
Micronutrient matched placebo
Interventions
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Polyphenol Supplement
Juice Plus Essentials, Berry Blend Capsules
Placebo Supplement
Micronutrient matched placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
Yes
Sponsors
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University of Parma
OTHER
University College Cork
OTHER
National Institute on Aging (NIA)
NIH
University of California, Los Angeles
OTHER
University of Ulster
OTHER
Responsible Party
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Principal Investigators
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Chris Gill, PhD
Role: PRINCIPAL_INVESTIGATOR
Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.
Locations
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Ulster University, Human Intervention Studies Unit
Coleraine, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Aoife Caffrey, PhD
Role: primary
Role: backup
Other Identifiers
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