ClinConnect ClinConnect Logo
Search / Trial NCT06507254

Polyphenols and Cognitive Decline

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jul 10, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Polyphenols Mediterranean Diet Gut Microbiome Alzheimers Disease

ClinConnect Summary

This clinical trial is studying whether a diet rich in polyphenols—natural compounds found in foods like cocoa, tea, and berries—can help older adults at risk of developing Alzheimer’s disease (AD) maintain better brain health and cognitive function. Researchers believe that these polyphenols may work by changing the bacteria in our gut, which in turn could have positive effects on the brain. The goal is to find out if regularly eating foods high in polyphenols can slow down cognitive decline and reduce the risk of dementia.

To participate, you must be at least 50 years old, overweight, and have a family history of Alzheimer's disease. You should not have any current cognitive impairments or certain health conditions that could interfere with the study. If you join, you will take either a polyphenol supplement or a placebo (a pill with no active ingredients) twice a day for a year. Throughout the study, you'll fill out food diaries, complete online questionnaires, and attend several in-clinic appointments where you'll undergo brain scans and cognitive tests. You'll also meet with a nutritionist to discuss your diet. This research could lead to dietary recommendations that help protect brain health in older adults.

Gender

ALL

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

About University Of California, Los Angeles

The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Arpana Church, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported