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Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers
Sponsor: Huazhong University of Science and Technology
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.
Official title: Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers in Middle-Aged and Older Adults: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-09-16
Completion Date
2026-12-30
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Fisetin intervention
Participants assigned to this intervention take capsules containing a fixed dose of Fisetin daily after breakfast.
Placebo
Participants assigned to this intervention take a capsule containing 500 mg of corn starch daily after breakfast.
Urolithin A intervention
Participants assigned to this intervention take capsules containing a fixed dose of Urolithin A daily after breakfast.
Locations (1)
Wuchang Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei, China