Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorHuazhong University of Science and Technology
About this trial
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
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Fisetin intervention
- Placebo
- Urolithin A intervention
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Huazhong University of Science and Technology
Lead sponsor
Wuhan Wuchang Hospital
Collaborator
Abinopharm, Inc
Collaborator
Source ClinicalTrials.gov