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Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers

NCT06990256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-21

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effects of Urolithin A (UA) and Fisetin on improving sleep and aging biomarkers in middle-aged and older adults. The main questions it aims to answer are:

Can UA and Fisetin improve sleep quality in middle-aged and older adults? Do these substances have a positive effect on aging biomarkers, such as inflammation, oxidative stress, and aging-related proteins? Researchers will compare four groups: Placebo group (a look-alike substance that contains no drug), 500 mg UA group, 500 mg Fisetin group and 300 mg UA + 200 mg Fisetin group.

Participants will:

Take the assigned capsules daily after breakfast for 12 weeks. Attend three clinic visits (baseline \[Week 0\], mid-intervention \[Week 4\], and post-intervention \[Week 12\]) including blood tests, sleep quality assessments (PSQI scale, actigraphy, polysomnography), and analysis of aging biomarkers (DNA methylation, inflammatory cytokines, etc.). Keep a sleep diary, complete a dietary survey, assess mental health, and measure frailty indicators. Provide stool and urine samples at baseline and post-intervention for gut microbiome and metabolite analysis. This trial aims to provide scientific evidence for the development of new nutritional intervention strategies to improve the healthy aging.

Conditions

  • Sleep Disorder
  • Aging

Interventions

DIETARY_SUPPLEMENT

Fisetin intervention

Participants assigned to this intervention take capsules containing a fixed dose of Fisetin daily after breakfast.

DIETARY_SUPPLEMENT

Placebo

Participants assigned to this intervention take a capsule containing 500 mg of corn starch daily after breakfast.

DIETARY_SUPPLEMENT

Urolithin A intervention

Participants assigned to this intervention take capsules containing a fixed dose of Urolithin A daily after breakfast.

Sponsors & Collaborators

  • Wuhan Wuchang Hospital

    collaborator UNKNOWN

  • Abinopharm, Inc

    collaborator NETWORK

  • Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2026-05-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990256 on ClinicalTrials.gov