Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers

NCT06990256 | Recruiting DMC

• 1 other identifier: 2025-008-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Aging

Keywords

Urolithin A; Fisetin; Sleep Disorder; Aging

Outcome Measures

Primary Outcomes (3)

• Subjective Sleep Quality Score

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), developed by psychiatrist Dr. Buysse in 1989. The PSQI includes seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, used sleep medication, and daytime dysfunction. Each component score ranges from 0 to 3, with a total score ranges from 0 to 21. Higher scores indicate poorer sleep quality, and a total score \>7 suggests clinically significant sleep impairment.

  From enrollment to the end of intervention at 12 weeks

• Chronotype

  Chronotype will be evaluated using the Morningness-Eveningness Questionnaire (MEQ), a self-reported scale consisting of 19 items assessing physiological and behavioral preferences across a 24-hour cycle. MEQ-5 will be used in this trial, which scores range from 4 to 25, with higher scores indicating a morning-oriented chronotype and lower scores reflecting an evening-oriented preference.

  From enrollment to the end of intervention at 12 weeks

• Polysomnography

  Polysomnography (PSG) is a comprehensive sleep assessment and the reference standard for objectively evaluating sleep physiology and sleep disorders. It records multiple signals during sleep, typically including electroencephalography, electrooculography, and electromyography, as well as respiratory airflow and effort, oxygen saturation, electrocardiography, and body position/limb movements, to characterize sleep stages, sleep architecture, and sleep-related events. PSG is commonly used to assess sleep-disordered breathing (e.g., obstructive sleep apnea), periodic limb movement disorder, and REM sleep behavior disorder. All PSG data in this study will be scored and analyzed according to American Academy of Sleep Medicine (AASM) guidelines.

  From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (16)

• Number of participants with abnormal blood and urine routine tests results

  From enrollment to the end of intervention at 12 weeks

• Homeostatic Model Assessment of Insulin Resistance

  From enrollment to the end of intervention at 12 weeks

• Frailty Assessment

  From enrollment to the end of intervention at 12 weeks

• Fatigue Severity Scale Score

  From enrollment to the end of intervention at 12 weeks

• Patient Health Questionnaire-9 Score

  From enrollment to the end of intervention at 12 weeks

Study Arms (4)

Urolithin A Treatment Group

EXPERIMENTAL

Take a intervention capsule (containing 500 mg of Urolithin A) once daily after breakfast for a total of 12 weeks.

Dietary Supplement: Urolithin A intervention

Fisetin Treatment Group

EXPERIMENTAL

Take a intervention capsule (containing 500 mg of Fisetin) once daily after breakfast for a total of 12 weeks.

Dietary Supplement: Fisetin intervention

Combined Urolithin A and Fisetin Treatment Group

EXPERIMENTAL

Take a intervention capsule (containing 300 mg of Urolithin A + 200 mg of Fisetin) once daily after breakfast for a total of 12 weeks.

Dietary Supplement: Fisetin intervention; Dietary Supplement: Urolithin A intervention

Placebo Control group

PLACEBO COMPARATOR

Take a placebo capsule (containing 500 mg of corn starch) once daily after breakfast for a total of 12 weeks.

Dietary Supplement: Placebo

Interventions

Fisetin intervention DIETARY_SUPPLEMENT

Participants assigned to this intervention take capsules containing a fixed dose of Fisetin daily after breakfast.

Combined Urolithin A and Fisetin Treatment Group; Fisetin Treatment Group

Placebo DIETARY_SUPPLEMENT

Participants assigned to this intervention take a capsule containing 500 mg of corn starch daily after breakfast.

Placebo Control group

Urolithin A intervention DIETARY_SUPPLEMENT

Participants assigned to this intervention take capsules containing a fixed dose of Urolithin A daily after breakfast.

Combined Urolithin A and Fisetin Treatment Group; Urolithin A Treatment Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Wuchang Hospital: collaborator
• Huazhong University of Science and Technology: lead
• Abinopharm, Inc: collaborator

Study Sites (1)

Wuchang Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Hui Xiong

CONTACT

+86 138 7122 6649; xh9613076@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)