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

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

Interventions

DIETARY_SUPPLEMENT

Urolithin A 500mg

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.

OTHER

Placebo

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.

Sponsors & Collaborators

• Charles University, Czech Republic

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-08

Primary Completion

2026-08-30

Completion

2026-12-31

Countries

• Czechia

Study Locations