NCT06507254
Polyphenols and Cognitive Decline
Recruiting
NAAges 50+InterventionalPreventionUniversity of California, Los AngelesInvestigator-initiated
~300 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Polyphenol SupplementPlacebo Supplement
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool
Measured over Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
+9 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Arpana Church, PhD · PRINCIPAL_INVESTIGATOR · The Regents of the University of California, Los Angeles
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
50+ Years of age
Male or Female
At enhanced risk of Alzheimer's Disease (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)
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.
Chronic Pain
What this trial measures
- Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stoolCollected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Measurement of metabolomics via stool specimen.
- Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - bloodCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Measurement of metabolomics via blood specimen.
- Differences in microbiome levels pre, mid, & post intervention - StoolCollected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
16S RNA sequencing to measure microbiome levels via stool specimen.
- Differences in microbiome levels pre & post intervention - BloodCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
16S RNA sequencing to measure microbiome levels via blood specimen.
- Differences in microbiome levels pre, mid, & post intervention - StoolCollected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12).
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
- Differences in microbiome levels pre, mid, & post intervention - BloodCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
- Differences in Cognitive Measures pre, mid, & post intervention - Executive FunctionCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized Stroop Neuro-psychological test; participants ability to correctly identify colors when words are printed in conflicting ink colors.
- Differences in Cognitive Measures pre, mid, & post intervention - Executive FunctionCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized Trails A \& B; participants ability to connect dots, in order, as quickly as possible.
- Differences in Cognitive Measures pre, mid, & post interventionCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Differences in Cognitive Measures pre, mid, and post intervention - Executive FunctioningCollected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized arithmetic task; participants ability to complete quick mental math.