Mitopure for Frailty

(MitoEM Trial)

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

26 Participants Needed

Trial Summary

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.

What evidence supports the effectiveness of the treatment Mitopure (Urolithin A) for frailty?

Research shows that Urolithin A, the active ingredient in Mitopure, can improve muscle health and mitochondrial function, which are important for reducing frailty. Clinical trials in elderly people have demonstrated that Urolithin A is safe and can enhance cellular health, potentially slowing aging and improving quality of life. ^{1 2 3 4 5}

Is Mitopure (Urolithin A) safe for human use?

Urolithin A, also known as Mitopure, has been shown to be safe in humans, with a favorable safety profile observed in clinical trials. It has been tested at doses up to 2,500 mg/day and is considered safe, with studies indicating it can improve mitochondrial health in elderly individuals. ^{1 2 3 4 5}

How does the drug Mitopure (Urolithin A) differ from other treatments for frailty?

Mitopure (Urolithin A) is unique because it enhances cellular health by promoting mitophagy (the process of removing damaged mitochondria) and improving mitochondrial function, which is crucial for muscle health and reducing inflammation. Unlike other treatments, it is a natural compound derived from foods like pomegranates and has shown potential in improving muscle function and preventing age-related decline in clinical studies. ^{1 2 3 5 6}

What is the purpose of this trial?

The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation

Research Team

Gilles Gouspillou, PhD

Principal Investigator

UQAM (University of Quebec at Montreal)

José Morais

Principal Investigator

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

Eligibility Criteria

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

I am not on any medication or have conditions that could affect the study's safety or results.

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.

I agree not to take any mitochondrial supplements or drink pomegranate juice during the study.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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), 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of the Natural Compound Urolithin A on Health, Disease, and Aging. [2021]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Urolithin A prevents streptozotocin-induced diabetic cardiomyopathy in rats by activating SIRT1. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Urolithin A as a Potential Agent for Prevention of Age-Related Disease: A Scoping Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A mechanistic insight into the biological activities of urolithins as gut microbial metabolites of ellagitannins. [2022]

5. Germany 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Mitophagy Activation by Urolithin A to Target Muscle Aging. [2023]