Influence of the Urolithin A on the Population With BMI Higher Than 30 During Restricted Eating.

NCT07377136 | Enrolling By Invitation

• 1 other identifier: 202509 P05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose. This study will test whether daily Urolithin A (500 mg) for 6 months helps adults with obesity lose weight while preserving functional muscle mass and improving markers of mitochondrial health, inflammation, and metabolism. All participants receive the same structured lifestyle program (nutrition and sleep guidance); half will receive Urolithin A and half a matching placebo. Background. Weight loss can improve health but may also reduce skeletal muscle, especially in people with obesity. Aging and obesity are both linked to mitochondrial dysfunction, impaired autophagy/mitophagy, oxidative stress, and low-grade inflammation. Urolithin A is a gut-derived, diet-related compound that promotes mitophagy and may support muscle function and metabolic health. Design. Single-center, randomized, placebo-controlled, parallel-group trial. About 100 adults aged 30-60 years with BMI \>30 kg/m² and elevated visceral adiposity will be enrolled and randomized in a 1:1 ratio (stratified by sex and age ≤45 vs ≥45 years). Blinding will include participants, study staff, and assessors. Intervention. Urolithin A 500 mg orally once daily vs matching placebo, for 24 weeks. A standardized lifestyle program for all participants: individualized energy restriction with higher protein intake, reduced carbohydrates, and time-restricted eating (11-hour eating window / 13-hour overnight fast); plus structured sleep-hygiene recommendations and light daily activity guidance. No other dietary supplements are allowed during the study. Main assessments. At baseline and regularly during the study, participants will undergo: Body composition by bioimpedance (InBody), including skeletal muscle and visceral fat indices. Muscle function (handgrip dynamometry; 30-second chair-stand). Cardiometabolic and inflammatory biomarkers from blood (standard biochemistry, lipids, glucose/HbA1c, CRP; exploratory cytokines/adipokines). Mitochondrial/aging biomarkers, including DNA-based epigenetic aging measures. Cardiovascular/ANS function (heart-rate variability and vascular indices; MaxPulse Medicore). Questionnaires on sleep quality, physical activity, and weight-management self-efficacy. Visits and duration. 6-month participation with baseline, 3-weekly check-ins, and a final visit for repeat testing and blood sampling. Outcomes. The study focuses on safety and on whether Urolithin A, compared with placebo, helps preserve functional muscle mass and improves mitochondrial, inflammatory, and metabolic biomarkers during weight loss. Who can join. Adults 30-60 years with obesity and higher visceral fat who are willing to follow the lifestyle program. Key medical exclusions (e.g., diabetes, active autoimmune disease, pregnancy) and supplement restrictions apply; full criteria are provided in the Eligibility section. Potential benefits and risks. Participants may benefit from weight loss support and close monitoring. Risks include blood draw discomfort and potential, usually mild, supplement-related side effects. Safety will be monitored throughout. Location and sponsor. The study is conducted at Charles University, Faculty of Medicine in Hradec Králové (Czech Republic) under the Department of Preventive Medicine.

Conditions

Obesity & Overweight

Keywords

obesity; urolithinA; restricted eating

Outcome Measures

Primary Outcomes (1)

• Change in Appendicular Skeletal Muscle Index (ASMI) by Bioimpedance

  ASMI = sum of lean mass in both arms and legs (kg) divided by height² (m²), derived from segmental bioimpedance (InBody). Primary comparison is change from baseline to Week 24 between Urolithin A and placebo using ANCOVA adjusting for baseline, sex, and age stratum. Higher ASMI reflects greater functional muscle mass.

  Baseline to Week 24 (end of intervention)

Secondary Outcomes (14)

• Change in Handgrip Strength (kg)

  Baseline to Week 24

• Change in Visceral Adipose Area (cm²) by Bioimpedance

  Baseline to Week 24

• Change in Percent Body Fat (%)

  Baseline to Week 24

• Glycemic Control (HbA1c)

  Baseline to Week 24

• LDL-C

  Baseline to Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Urolithin A

EXPERIMENTAL

Dietary Supplement: Urolithin A 500mg

Interventions

Urolithin A 500mg DIETARY_SUPPLEMENT

Dietary Supplement: Urolithin A (500 mg) - Intervention Description Oral Urolithin A 500 mg capsule once daily for 24 weeks, preferably with the first meal. GMP-manufactured product; identical capsule shell/appearance to placebo. No dose titration. No other dietary supplements allowed during participation. Adherence assessed by pill counts and visit logs; temporary interruption permitted for adverse events per protocol. Co-administered with the same standardized lifestyle program as the control arm.

Urolithin A

Placebo OTHER

Placebo Comparator: Matching Placebo - Intervention Description Matching inert capsule (no Urolithin A), same size, color, shell, and packaging as active product; once daily for 24 weeks with the first meal. Dispensed in coded kits to maintain masking. Participants receive the same lifestyle program as the active arm. Use of other dietary supplements is prohibited during the trial.

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 30-60 years (inclusive) at screening
• BMI \> 30 kg/m² at screening
• Visceral fat level ≥ 12 by segmental bioimpedance (InBody) at screening
• Able and willing to follow the standardized lifestyle program (individualized energy restriction with higher protein, reduced carbohydrates, time-restricted eating 11:13) and sleep-hygiene guidance for 24 weeks
• Willing to attend baseline and \~3-weekly follow-ups; undergo blood draws, bioimpedance, MaxPulse testing, and muscle strength/endurance tests; and complete questionnaires (WEL, PSQI, GPAQ)
• Medication stability: chronic medications (e.g., treated hypertension, antidepressants) stable for ≥3 months before baseline; only clinically necessary changes allowed during the study
• Permitted conditions/therapies (if stable): common allergies/atopic eczema; food intolerances; contraception and menopausal hormone therapy
• Women of childbearing potential: negative pregnancy test at baseline; agreement to use highly effective contraception during the study and for 4 weeks after last dose; not breastfeeding
• Able to provide written informed consent

You may not qualify if:

• Known thyroid disease (untreated/unstable hypothyroidism or hyperthyroidism)
• Type 2 diabetes mellitus (diagnosed or on glucose-lowering therapy)
• Autoimmune disease, including psoriasis
• Inflammatory bowel disease or other chronic inflammatory GI disorders (e.g., Crohn's disease, celiac disease)
• Dyslipidemia treated with statins
• Pregnancy, lactation, or planned pregnancy during the study period
• Active malignant disease
• Cognitive impairment or neurodegenerative disease that may affect consent or adherence
• Severe psychiatric disorder that would preclude participation (e.g., severe major depression) or unstable depression/medication changes within the past 3 months
• Uncontrolled comorbidity or decompensated chronic disease (e.g., uncontrolled hypertension; systolic ≥175 mmHg at screening)
• Severe or limiting musculoskeletal condition preventing participation in assessments or the lifestyle program
• Use of non-study dietary supplements (vitamins, herbal/nutraceutical products) that the participant is unwilling or unable to discontinue from baseline through end of study
• Known allergy/intolerance to Urolithin A or capsule excipients
• Any condition that, in the investigator's judgment, makes participation unsafe or could compromise data integrity

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Charles University, Faculty of Medicine in Hradec Kralove

Hradec Králové, 500 03, Czechia

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: only those above
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single-center, randomized, placebo-controlled, parallel-group trial in adults aged 30-60 years with BMI \>30 kg/m² and elevated visceral adiposity. Participants are randomized 1:1 to Urolithin A 500 mg once daily vs matching placebo for 24 weeks, on top of a standardized lifestyle program (individualized energy restriction with higher protein, reduced carbohydrates, time-restricted eating 11:13, and sleep-hygiene optimization). Randomization is stratified by sex (male/female) and age (≤45/≥45). Study visits include baseline, \~3-weekly follow-ups, and an end-of-study visit. Primary domain is preservation of functional muscle mass during weight loss; key secondary domains include body composition, cardiometabolic/inflammatory markers, mitochondrial/aging biomarkers, autonomic/vascular indices, and patient-reported outcomes.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: January 29, 2026
• Study Start: October 8, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)