Mitopure for Frailty

(MitoEM Trial)

No longer recruiting at 1 trial location

Overseen By Gilles Gouspillou, Gouspillou

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Amazentis SA

Disqualifiers: Chronic disease, Drug abuse, Alcohol abuse, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the supplement Mitopure (Urolithin A) might enhance muscle energy production in frail older adults. Researchers aim to determine if taking Mitopure for eight weeks can improve muscle function by enhancing mitochondria, the cell's power plants. Individuals who have experienced prolonged weakness or fatigue and meet specific health criteria may qualify for this study. Participants will be randomly assigned to take either Mitopure or a placebo (a harmless pill with no active ingredient) for comparison. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve muscle health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that medication requirements that may interfere with the study results could be a concern. It's best to discuss your specific medications with the study team to see if they might affect your participation.

Is there any evidence suggesting that Mitopure (Urolithin A) is likely to be safe for humans?

Research shows that Urolithin A, the main ingredient in Mitopure, is safe for people. Studies have found it well-tolerated even at doses up to 2,500 mg per day. One trial found that participants taking Urolithin A did not experience significant side effects. These results suggest that Mitopure is generally safe for older adults, which is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for frailty, which often focus on physical activity and nutritional supplements, Mitopure (Urolithin A) targets cellular health by enhancing mitochondrial function. This is exciting because mitochondria are the powerhouses of our cells, and improving their function can boost energy levels and muscle strength, potentially reversing frailty. Researchers are particularly enthusiastic about Mitopure's ability to support healthy aging at a cellular level, offering a novel approach compared to existing treatments.

What evidence suggests that Mitopure might be an effective treatment for frailty?

Research has shown that Urolithin A, the key ingredient in Mitopure, can improve cell health, particularly in older adults. It enhances the function of mitochondria, the energy centers in cells, and removes damaged ones. This process can lead to stronger muscles and improved endurance. In past studies, participants who took Urolithin A performed better in physical tests, such as walking farther in six minutes. In this trial, participants will receive either Mitopure (Urolithin A) or a placebo to assess its potential benefits for improving muscle function and overall health in frail older adults. ^{1 4 5 6 7}

Who Is on the Research Team?

José Morais

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Gilles Gouspillou, PhD

Principal Investigator

UQAM (University of Quebec at Montreal)

Are You a Good Fit for This Trial?

This trial is for frail older adults over the age of 65 who are experiencing muscle weakness or wasting. Participants should be interested in testing a supplement that might improve muscle health.

Inclusion Criteria

I am between 65-85 years old, do not smoke, and am considered frail.

A body mass index between 18 to 35 kg/m2

Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria

I have not lost or donated more than 500mL of blood in the past 3 months (if male) or 4 months (if female).

I am not willing or able to have a muscle biopsy.

Underlying chronic disease, which in the opinion of the investigator, would interfere with study participation or the validity of the measurements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mitopure (Urolithin A) or placebo for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mitopure (Urolithin A)

Trial Overview The study tests Mitopure (Urolithin A) to see if it can enhance mitochondrial quality in muscles after 8 weeks. It's a controlled test where some get Mitopure and others get a placebo, without knowing which one they receive.

How Is the Trial Designed?

Group I: Mitopure (Urolithin A) Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Mitopure (Urolithin A) is already approved in United States for the following indications:

Approved in United States as Mitopure for:

• Generally Recognized as Safe (GRAS) for dietary supplement use

Who Is Running the Clinical Trial?

Amazentis SA

Lead Sponsor

Trials

21

Recruited

1,400+

Université du Québec a Montréal

Collaborator

Trials

28

Recruited

5,600+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

Urolithins, metabolites from ellagitannin-rich foods, show promising biological activities such as anti-inflammatory, anticancer, and antiaging effects, with mechanisms involving the modulation of key cellular pathways like MDM2-p53 interaction and NF-κB activity.

A recent clinical trial demonstrated that urolithin A is safe at doses up to 2,500 mg/day and can enhance mitochondrial biomarkers in elderly patients, highlighting its potential as a therapeutic agent for age-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mechanistic insight into the biological activities of urolithins as gut microbial metabolites of ellagitannins. Hasheminezhad, SH., Boozari, M., Iranshahi, M., et al.[2022]

Mitochondrial dysfunction is a key factor in age-related loss of skeletal muscle function, and the decline in mitophagy during aging negatively affects muscle performance.

Urolithin A, a natural postbiotic, has been shown to enhance mitophagy and mitochondrial function, leading to improved muscle function in various experimental models and clinical studies, suggesting it could be a beneficial intervention for age-related muscle decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitophagy Activation by Urolithin A to Target Muscle Aging. Faitg, J., D'Amico, D., Rinsch, C., et al.[2023]

Urolithin A (UA), derived from gut bacteria processing ellagitannins found in foods like pomegranate and berries, has been shown to enhance cellular health by promoting mitophagy and improving mitochondrial function while reducing inflammation.

Recent clinical trials indicate that UA supplementation can provide benefits for muscle health in elderly individuals, suggesting its potential as a nutritional intervention to combat aging and age-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Natural Compound Urolithin A on Health, Disease, and Aging. D'Amico, D., Andreux, PA., Valdés, P., et al.[2021]

Urolithin A (UA), a compound produced from gut bacteria digesting certain polyphenols, has been identified as a potential supplement that can induce mitophagy, which may help combat age-related diseases by improving mitochondrial function.

A review of 15 studies suggests that UA supplementation could slow aging and prevent age-related pathologies, highlighting its importance in maintaining mitochondrial health and reducing inflammation as we age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urolithin A as a Potential Agent for Prevention of Age-Related Disease: A Scoping Review. Kothe, B., Klein, S., Petrosky, SN.[2023]

Urolithin A significantly improves heart function and structure in diabetic rats, reducing harmful cardiac markers and collagen deposition, indicating its potential as a protective treatment against diabetic cardiomyopathy.

The protective effects of urolithin A are linked to the activation of SIRT1 signaling, which enhances antioxidant defenses and reduces inflammation, as evidenced by changes in various molecular markers and the prevention of these benefits by a SIRT1 inhibitor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urolithin A prevents streptozotocin-induced diabetic cardiomyopathy in rats by activating SIRT1. Albasher, G., Alkahtani, S., Al-Harbi, LN.[2022]

Urolithin A (UA) was found to be safe for consumption in a first-in-human clinical trial involving healthy, sedentary elderly individuals, with a favorable safety profile observed during the study.

After 4 weeks of treatment with UA at doses of 500 mg and 1,000 mg, participants showed changes in plasma acylcarnitines and improved skeletal muscle mitochondrial gene expression, indicating potential benefits for mitochondrial and cellular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mitophagy activator urolithin A is safe and induces a molecular signature of improved mitochondrial and cellular health in humans. Andreux, PA., Blanco-Bose, W., Ryu, D., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06556706?term=AREA%5BInterventionSearch%5D(urolithin)&rank=5

Impact of Urolithin A (Mitopure) on Mitochondrial Quality in ... Frail (as defined by the Fried frailty criteria)nonsmoking participants in the age group of 65 to 85 years old, both male and female. A body mass index between ...

2. withpower.com withpower.com/trial/phase-muscular-atrophy-7-2024-06374

Mitopure for Frailty · Info for Participants · Clinical Trial 2025 Clinical trials in elderly people have demonstrated that Urolithin A is safe and can enhance cellular health, potentially slowing aging and improving quality of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1471491421001180

Impact of the Natural Compound Urolithin A on Health, ... UA enhances cellular health by increasing mitophagy and mitochondrial function and reducing detrimental inflammation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8777576/

Effect of Urolithin A Supplementation on Muscle Endurance ... This randomized clinical trial evaluates the improvement in the 6-minute walk distance test and in leg and hand muscle endurance after use of urolithin A in ...

5. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Urolithin_A_UPDATE_%28supplement%29.pdf

Urolithin A Neuroscientists evaluate the potential benefit (or harm) for brain health, as well as for age-related health concerns that can affect brain health (e.g.,.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06556706/impact-of-urolithin-a-mitopure-on-mitochondrial-quality-in-muscle-of-frail-older-adults

Impact of Urolithin A (Mitopure) on Mitochondrial Quality in ... The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35050355/

Effect of Urolithin A Supplementation on Muscle Endurance ... Conclusions and relevance: This randomized clinical trial found that urolithin A supplementation was safe and well tolerated in the assessed ...