{"type":"trials","record":{"id":68,"source_id":"clinicaltrials-gov","external_id":"NCT06990256","title":"Evaluation of Urolithin A and Fisetin on Improving Sleep and Aging Biomarkers","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.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Huazhong University of Science and Technology","enrollment":83,"countries":["China"],"start_date":"2025-09-16","completion_date":"2026-12-30","last_update_date":"2026-08-10","source_url":"https://clinicaltrials.gov/study/NCT06990256","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:44:59.105435+00:00","last_seen_at":"2026-09-25T06:15:54.38+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"30 Years to 75 Years","comparator":"Placebo Control group","organization":"Huazhong University of Science and Technology","interventions":["Fisetin intervention","Placebo","Urolithin A intervention"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Subjective Sleep Quality Score — From enrollment to the end of intervention at 12 weeks","Chronotype — From enrollment to the end of intervention at 12 weeks","Polysomnography — From enrollment to the end of intervention at 12 weeks","Number of participants with abnormal blood and urine routine tests results — From enrollment to the end of intervention…","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","Generalized Anxiety Disorder Scale Score — From enrollment to the end of intervention at 12 weeks","Determination of Plasma Immunoglobulin Levels (g/L) — From enrollment to the end of intervention at 12 weeks","DNA Methylation Clock — From enrollment to the end of intervention at 12 weeks","Profile of Mood States-Short Form (Chinese Version) Score — From enrollment to the end of intervention at 12 weeks","Plasma Interleukin Levels — From enrollment to the end of intervention at 12 weeks","Gut Microbiota Diversity Analysis (Based on 16S rRNA Gene Sequencing) — From enrollment to the end of intervention at 1…","D-lactic acid level — From enrollment to the end of intervention at 12 weeks","NAD+ Level Measurement — From enrollment to the end of intervention at 12 weeks","Quality of Life Assessment — From enrollment to the end of intervention at 12 weeks","Arterial stiffness assessment — From enrollment to the end of intervention at 12 weeks","Cardiopulmonary exercise testing — From enrollment to the end of intervention at 12 weeks"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Sleep Disorder","Aging","Fisetin intervention","Placebo","Urolithin A intervention"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: urolithin a.","quality_checked_at":"2026-09-25T06:16:07.48358+00:00","duplicate_cluster_key":"id:nct06990256","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-09-16 to 2026-12-30","comparator":"Placebo Control group","confidence":"structured-source","population":"ALL · 30 Years to 75 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:15:54.395Z","intervention":["Fisetin intervention","Placebo","Urolithin A intervention"],"participants":83,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Subjective Sleep Quality Score — From enrollment to the end of intervention at 12 weeks","Chronotype — From enrollment to the end of intervention at 12 weeks","Polysomnography — From enrollment to the end of intervention at 12 weeks","Number of participants with abnormal blood and urine routine tests results — From enrollment to the end of intervention…","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","Generalized Anxiety Disorder Scale Score — From enrollment to the end of intervention at 12 weeks","Determination of Plasma Immunoglobulin Levels (g/L) — From enrollment to the end of intervention at 12 weeks","DNA Methylation Clock — From enrollment to the end of intervention at 12 weeks","Profile of Mood States-Short Form (Chinese Version) Score — From enrollment to the end of intervention at 12 weeks","Plasma Interleukin Levels — From enrollment to the end of intervention at 12 weeks","Gut Microbiota Diversity Analysis (Based on 16S rRNA Gene Sequencing) — From enrollment to the end of intervention at 1…","D-lactic acid level — From enrollment to the end of intervention at 12 weeks","NAD+ Level Measurement — From enrollment to the end of intervention at 12 weeks","Quality of Life Assessment — From enrollment to the end of intervention at 12 weeks","Arterial stiffness assessment — From enrollment to the end of intervention at 12 weeks","Cardiopulmonary exercise testing — From enrollment to the end of intervention at 12 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"biological-age-biomarkers","is_published":true,"match_reasons":["Title contains controlled term: aging biomarker.","Abstract contains controlled term: aging biomarker.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Biological age biomarkers","slug":"biological-age-biomarkers"}},{"topic_slug":"sleep","is_published":true,"match_reasons":["Title contains controlled term: sleep.","Abstract contains controlled term: sleep.","Source terminology contains: sleep.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sleep","slug":"sleep"}},{"topic_slug":"urolithin-a","is_published":true,"match_reasons":["Title contains controlled term: urolithin a.","Abstract contains controlled term: urolithin a.","Source terminology contains: urolithin a.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Urolithin A","slug":"urolithin-a"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/68","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}