Actively Recruiting
Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers in Middle-Aged and Older Adults: A Randomized Controlled Trial
Led by Huazhong University of Science and Technology · Updated on 2026-01-21
80
Participants Needed
1
Research Sites
30 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
This research aims to evaluate the effects of Urolithin A (UA) and Fisetin on sleep quality and aging biomarkers in middle-aged and older adults aged 30 to 75 years. The study addresses whether UA and Fisetin can improve sleep and positively influence markers related to aging, such as inflammation, oxidative stress, and aging-related proteins. It is a randomized controlled trial that includes four groups: placebo, UA alone, Fisetin alone, and a combination of UA and Fisetin. Participants will take one capsule every day after breakfast for 12 weeks, according to their assigned group. The four groups include a 500 mg UA group, a 500 mg Fisetin group, a combined 300 mg UA plus 200 mg Fisetin group, and a placebo group receiving a corn starch capsule. The intervention period is followed by three clinic visits at baseline, mid-intervention (week 4), and post-intervention (week 12), where various assessments are conducted. During the study, participants will undergo blood tests, sleep quality evaluations using questionnaires, actigraphy, and polysomnography, as well as aging biomarker analyses such as DNA methylation and inflammatory cytokines. They will also keep sleep diaries, complete dietary and mental health assessments, and provide stool and urine samples for gut microbiome and metabolite analysis. The primary outcomes focus on sleep quality and frailty, while secondary outcomes examine metabolic, immune, inflammatory markers, and quality of life. The study will monitor participants throughout the 12-week period to gather comprehensive data on the effects of the interventions.
CONDITIONS
Brief 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 to 75 years
- Total score greater than 5 points on the Pittsburgh Sleep Quality Index (PSQI)
- 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 one time or less per week during the trial period
You will not qualify if you...
- Participated in any clinical trials or dietary/exercise intervention programs within the past 3 months or currently
- Diagnosed with major mental disorders or family history, or currently using psychotropic or mood-regulating medications
- Experienced major psychological trauma personally or within the family in the past 3 months
- Have severe diseases affecting inflammation or endocrine systems such as severe obesity, uncontrolled diabetes, myocardial infarction, or cerebral infarction
- Currently using hormonal medications, beta-blockers, steroids, or non-steroidal anti-inflammatory drugs (NSAIDs)
- Used medications affecting sleep or aging biomarkers like melatonin, antidepressants, or anxiolytics within the past 3 months
- Plans for relocation or long-term travel within the next 6 months that may prevent continuous participation and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take one capsule daily after breakfast containing either Urolithin A, Fisetin, a combination of both, or placebo for 12 weeks to evaluate effects on sleep and aging biomarkers.
3 visits at baseline, week 4, and week 12
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
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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