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NCT06507254 · ClinicalTrials.gov registry record · NA

Polyphenols and Cognitive Decline

A NA study of Cognitive Decline and Cognitive Dysfunction, sponsored by University of California, Los Angeles.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
1
Study location

NCT06507254 is a NA study of Cognitive Decline and Cognitive Dysfunction that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 300 participants, below the 1,145-participant average among 61 other Cognitive Decline trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06507254, a NA study of Cognitive Decline and Cognitive Dysfunction, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
1
Study location

Study 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 to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. A traditional Mediterranean diet, rich in polyphenols (PPs), may prevent or delay the onset of cognitive dysfunction in older adults, preserving healthy brain structure and function, and lowering the risk of AD. These effects, mediated in part by gut microbiome-derived PP metabolites, highlight the role alterations in the brain-gut microbiome system play in neurodegeneration. Moreover, high levels of circulating phenyl-y-valerolactones, neuroprotective compounds, exclusively produced by gut microbiota from flavan-3-ol-rich foods (e.g., cocoa, tea, berries) are associated with delaying the onset of cognitive dysfunction in older adults. Intake of such PPs can also change gut microbial composition and function, altering the physiology of the hosts secondary bile acid (BA) pool, affecting regulatory and signaling functions in the brain as well as cognitive decline and AD. The investigators hypothesize that, in older adults with enhanced AD risk, dietary intake of PPs maintains healthier brain features and cognitive function, and that this beneficial effect is mediated by gut microbiota metabolites of PPs and BAs. In this multi-PI application by leaders in the field of brain-gut microbiome interactions, the investigators will conduct a year-long, multi-center, randomized double-blind placebo-controlled study in 300 older adults in the United States (validation sample of 100 from Northern Ireland) who are at enhanced risk of developing AD. Ultimately, the investigators will establish the protective effects of regular dietary PP intake on cognitive function and on brain-gut microbiome interactions, ideally allowing the development of effective dietary regimes

Interventions

  • DIETARY_SUPPLEMENT Polyphenol Supplement
  • DIETARY_SUPPLEMENT Placebo Supplement

Study Locations (1)

California

  • University of California, Los Angeles - Los Angeles

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2025-01-09
Est. Completion 2029-12-31
Phase NA

What the Registry Record Tells You About NCT06507254

The ClinicalTrials.gov registry entry for NCT06507254 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,145-participant average among 61 other Cognitive Decline trials with a reported enrollment target (74% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cognitive Decline appearing as the primary indexed condition, and to 2 interventions - of which Polyphenol Supplement is the first listed.

NCT06507254 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT06507254 about?

NCT06507254 is a clinical study titled "Polyphenols and Cognitive Decline". 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 to develop new strategies for healthy cognitive aging, including interventions to slow or prevent c...

What is the current status of trial NCT06507254?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2025-01-09. Estimated completion is 2029-12-31.

What conditions does trial NCT06507254 study?

This clinical trial studies the following conditions: Cognitive Decline, Cognitive Dysfunction.

What interventions are being tested in trial NCT06507254?

The interventions under investigation include: Polyphenol Supplement (DIETARY_SUPPLEMENT), Placebo Supplement (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06507254?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06507254 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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