Status:
RECRUITING
Polyphenols and Cognitive Decline
Lead Sponsor:
University of California, Los Angeles
Conditions:
Cognitive Decline
Cognitive Dysfunction
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06507254
Start Date
January 9 2025
End Date
December 31 2029
Last Update
May 31 2025
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095