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RECRUITING
NCT06990256
NA

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

Sponsor: Huazhong University of Science and Technology

View on ClinicalTrials.gov

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

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.

Locations (1)

Wuchang Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, China