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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Fisetin intervention
Dietary supplementParticipants assigned to this intervention take capsules containing a fixed dose of Fisetin daily after breakfast.
Placebo
Dietary supplementParticipants assigned to this intervention take a capsule containing 500 mg of corn starch daily after breakfast.
Urolithin A intervention
Dietary supplementParticipants assigned to this intervention take capsules containing a fixed dose of Urolithin A daily after breakfast.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Urolithin A Treatment GroupExperimental treatment 1 intervention
Group B: Fisetin Treatment GroupExperimental treatment 1 intervention
Group C: Combined Urolithin A and Fisetin Treatment GroupExperimental treatment 2 interventions
Group D: Placebo Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of intervention at 12 weeks2
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.
Time frame
From enrollment to the end of intervention at 12 weeks3
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.
Time frame
From enrollment to the end of intervention at 12 weeksSecondary outcomes
1
Number of participants with abnormal blood and urine routine tests results
We will conduct blood routine and urine routine tests, and report the number of people with abnormal tests results. The tests indicators include: Red Blood Cell Count (RBC), Hemoglobin (Hb), Hematocrit (Hct), White Blood Cell Count (WBC), Neutrophils (Neut# and Neut%), Lymphocytes (Lym# and Lym%), Monocytes (Mono# and Mono%), Platelet Count (PLT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Urine Physical Characteristics (Appearance, specific gravity, pH), Urine Biochemical Analysis (Protein, Glucose, Occult blood, Leukocytes, Erythrocytes, and Bacteria). Any abnormal results will be marked on the laboratory report.
Time frame
From enrollment to the end of intervention at 12 weeks2
Homeostatic Model Assessment of Insulin Resistance
Plasma samples collected at different time points will be classified and labeled with two sets of each sample. An automated hematology analyzer in the hospital will be used.The degree of Insulin Resistance (IR) and sensitivity will be calculated by the Homeostatic Model Assessment (HOMA-IR) using the formula: HOMA-IR=(Fasting Insulin (μIU/mL) × Fasting Glucose (mmol/L) )/22.5
Time frame
From enrollment to the end of intervention at 12 weeks3
Frailty Assessment
Frailty status will be evaluated using the Fried Frailty Phenotype. The Fried Frailty Phenotype includes exhaustion, weight loss, low physical activity, slow gait speed, and grip strength measurement.For consistency with previous literature, participants who meet 3 or more criteria will be diagnosed as frailty, those who meet 1 or 2 criteria will be classified as prefrailty, and those who meet none of the criteria will be considered as nonfrailty.
Time frame
From enrollment to the end of intervention at 12 weeks4
Fatigue Severity Scale Score
The Fatigue Severity Scale will be used to measure the fatigue score of participants.Evaluates fatigue severity over the past week through 9 items, with each item scored from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 9 to 63. Higher scores indicate more severe fatigue.
Time frame
From enrollment to the end of intervention at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Huazhong University of Science and Technology
Lead sponsor
Wuhan Wuchang Hospital
Collaborator
Abinopharm, Inc
Collaborator
Source ClinicalTrials.gov