Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Wuchang Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
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
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