Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers
Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers in Middle-Aged and Older Adults: A Randomized Controlled Trial
Huazhong University of Science and Technology
80 participants
Sep 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 ≤1 time per week during the trial period;
Exclusion Criteria7
- 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 (e.g., death of a close relative, significant financial loss) 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 or poorly controlled blood glucose, 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, which may hinder continuous intervention and follow-up.
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Interventions
Participants assigned to this intervention take capsules containing a fixed dose of Fisetin daily after breakfast.
Participants assigned to this intervention take a capsule containing 500 mg of corn starch daily after breakfast.
Participants assigned to this intervention take capsules containing a fixed dose of Urolithin A daily after breakfast.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06990256