Urolithin A and Fisetin to improve sleep and markers of aging
Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers in Middle-Aged and Older Adults: A Randomized Controlled Trial
This trial will test whether taking Urolithin A or Fisetin daily can improve sleep quality and aging-related biomarkers in middle-aged and older adults who have poor sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06990256 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled trial that will enroll 80 adults aged 30–75 with poor sleep (PSQI > 5) and assign them to one of four groups: placebo, 500 mg Urolithin A, 500 mg Fisetin, or a combination of 300 mg Urolithin A + 200 mg Fisetin for 12 weeks. Participants will take one capsule daily after breakfast and attend three clinic visits at baseline, week 4, and week 12 for blood draws, sleep assessments (PSQI, actigraphy, and polysomnography), and biomarker collection. Primary outcomes are subjective and objective sleep quality and frailty measures, while secondary outcomes include inflammatory and metabolic markers, DNA methylation, gut microbiota, and quality of life. The trial includes sleep diaries and dietary monitoring to control confounders.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30–75 with poor sleep (PSQI > 5) who can attend three in-person visits, use mobile devices for study tasks, and agree to limited caffeine/alcohol during the trial.
Not a fit: People with major psychiatric disorders, severe inflammatory or endocrine diseases, recent participation in other interventions, or those without sleep disturbance are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, these supplements could offer a low-risk, widely accessible way to improve sleep and favorably shift biological aging markers in middle-aged and older adults.
How similar studies have performed: Preclinical data and small human studies suggest Urolithin A has mitophagy/anti-inflammatory effects and fisetin has senolytic activity, but combined, placebo-controlled trials focusing on sleep and aging biomarkers are still limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Wuhan, Hubei
- Wuchang Hospital Affiliated to Wuhan University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Hui Xiong
- Email: xh9613076@163.com
- Phone: +86 138 7122 6649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.