NCT06990256 Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers
| NCT ID | NCT06990256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Sleep Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-09-16 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06990256 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Sleep Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06990256 currently recruiting?
Yes, NCT06990256 is actively recruiting participants. Contact the research team at xh9613076@163.com for enrollment information.
Where is the NCT06990256 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06990256 clinical trial?
NCT06990256 is sponsored by Huazhong University of Science and Technology. The trial plans to enroll 80 participants.