Actively Recruiting

Phase Not Applicable
Age: 30Years - 75Years
All Genders
NCT06990256

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

Led by Huazhong University of Science and Technology · Updated on 2026-01-21

80

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

Sponsors

H

Huazhong University of Science and Technology

Lead Sponsor

W

Wuhan Wuchang Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 30-75 years
  • Total score > 5 points on the Pittsburgh Sleep Quality Index (PSQI) for sleep quality assessment
  • Able to use personal mobile devices for WeChat, internet access, and related operations
  • Informed about the intervention trial and willing to undergo sleep monitoring and other examinations during the study
  • Commitment to consume coffee, strong tea, or alcohol 3 time per week during the trial period
Not Eligible

You will not qualify if you...

  • Participation in any clinical trials or dietary/exercise intervention programs within the past 3 months or concurrently
  • Diagnosis of major mental disorders or family history thereof, or current use of psychotropic drugs or mood-regulating medications
  • Experiencing major psychological trauma personally or within the family in the past 3 months
  • Severe diseases affecting inflammatory levels and/or endocrine components (e.g., severe obesity, uncontrolled diabetes, myocardial infarction, cerebral infarction)
  • Current use of hormonal medications, beta-blockers, steroids, non-steroidal anti-inflammatory drugs (NSAIDs), etc.
  • Use of medications potentially affecting sleep or aging biomarkers (e.g., melatonin, antidepressants, anxiolytics) within the past 3 months
  • Plans for relocation or long-term travel within the next 6 months that may hinder continuous intervention and follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Wuchang Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

Loading map...

Research Team

H

Hui Xiong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here