Actively Recruiting
The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults
Led by Amazentis SA · Updated on 2026-03-31
120
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
A
Amazentis SA
Lead Sponsor
A
Atlantia Food Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomised, double-blind, placebo-controlled, parallel study to assess the effects of Urolithin A (Mitopure®) supplementation on muscle strength and performance in healthy middle-aged adults. Participants will be randomized to consume Mitopure® (500 mg), Mitopure® (1000 mg), or placebo once daily for 6 months.
CONDITIONS
Official Title
The Effect of Urolithin A (Mitopure®) Supplementation on Muscle Strength in Healthy Middle-Aged Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able to give written informed consent.
- Be between 40 to 65 years of age, inclusive.
- Have a BMI between 25.0 and 34.9 kg/m2.
- Have low physical activity levels as assessed by the International Physical Activity Questionnaire (IPAQ).
- Have a low VO2 peak (less than 35 mL/kg/min via ergometer prior to baseline).
- Willing to avoid exercising 48 hours prior to study visits and maintain low physical activity during the study.
- Willing to avoid caffeine and other stimulants 12 hours before exercise per study guidelines.
- Willing to consume the Study Product daily for the study duration.
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Of childbearing potential but not using effective contraception or abstinence as defined.
- History of drug or alcohol abuse exceeding national recommended limits.
- Consuming large quantities of pomegranate juice, walnuts, or frequent consumers of raspberries, strawberries, or cloudberries within 2 weeks.
- Chronic nicotine use.
- Unable to swallow capsules.
- Hypersensitive or dietary restrictions to any Study Product components.
- Unstable body weight or recent participation in weight loss program within 12 weeks.
- Significant acute or chronic health conditions that risk safety or affect study results, including recent major illness/surgery, severe cardiovascular disease, liver disease, kidney disease, gastrointestinal disease, uncontrolled thyroid or diabetes, metallic implants, or conditions requiring chemotherapy or immunotherapy.
- Use of medications or supplements that interfere with the study, including statins, anxiolytics, antidepressants, antipsychotics, oral anti-infectives, proton pump inhibitors, corticosteroids, GLP-1 agonists, or supplements for muscle building or mitochondrial boosting within specified timeframes.
- Blood donation within 8 weeks prior to screening.
- Considered unlikely to comply with study visits or requirements.
- Participation in other clinical studies without sufficient washout period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Atlantia Clinical Trials
Cork, Ireland, T23 R50R
Actively Recruiting
Research Team
B
Brad Currier, PhD
CONTACT
A
Anurag Singh, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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