Protein Supplement + Urolithin A for Muscle Atrophy

Overseen By Brad Currier

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Corticosteroids, Antibiotics, Anabolic steroids, others

Disqualifiers: Orthopedic, Psychiatric, Gastrointestinal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a protein drink, with or without Urolithin A, can prevent muscle loss when a knee brace restricts movement. Urolithin A, found in foods like pomegranates and nuts, might enhance muscle health. Participants will wear a knee brace to simulate muscle disuse and consume either a protein supplement alone or with Urolithin A. Healthy, non-smoking men without orthopedic issues may qualify for this study. As an unphased trial, this study provides a unique opportunity to advance understanding of muscle health and the potential benefits of natural compounds.

Do I need to stop taking my current medications for the trial?

Yes, you need to stop taking certain medications and supplements, like corticosteroids, antibiotics, anabolic steroids, creatine, whey protein, casein, and branched-chain amino acids, at least 45 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Urolithin A is generally safe and well tolerated. In studies where participants took Urolithin A for 120 days, no major side effects occurred. These studies also noted improvements in muscle strength and endurance. Other research found it safe for older adults, with benefits for muscle and energy health. Although Urolithin A occurs in foods like pomegranates and nuts, taking it as a supplement appears safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for muscle atrophy, which often focus on exercise and traditional protein supplements, the combination of a protein supplement with Urolithin A offers a novel approach. Urolithin A is a compound that can improve mitochondrial function, potentially enhancing muscle strength and endurance by boosting the energy efficiency of cells. Researchers are excited about this treatment because it targets the underlying cellular mechanisms, offering a potentially more effective solution for muscle preservation and growth. This could lead to faster and more sustainable improvements in muscle health compared to existing options.

What evidence suggests that this trial's treatments could be effective for muscle atrophy?

This trial will compare a protein supplement with a protein supplement combined with Urolithin A. Research has shown that Urolithin A can boost muscle strength by about 12%. It may help maintain muscle strength and improve endurance, especially during periods of inactivity, such as an injury. Urolithin A also supports mitochondrial health, which is crucial because mitochondria provide energy to cells. Combining a protein supplement with Urolithin A has improved muscle health, leading to better strength and endurance. These findings suggest that adding Urolithin A to a protein supplement could help reduce muscle loss during inactivity. ^{1 2 3 4 5}

Who Is on the Research Team?

Stuart Phillips

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for healthy, non-smoking men aged 18-30 with a BMI of 20-30 kg/m^2. Participants must not have orthopedic issues affecting the knee, gastrointestinal conditions, excessive alcohol use, or allergies to study ingredients. They can't be on certain medications or supplements that affect muscle health.

Inclusion Criteria

Healthy, non-smoking

BMI between 20 and 30 kg/m^2

No orthopedic issues that would preclude participation in the knee bracing protocol

Exclusion Criteria

Subject has any concurrent medical, orthopedic, or psychiatric requirements that, in the opinion of the investigators, would compromise their ability to comply with the study requirements

Allergy or sensitivity to study ingredients

Clinically significant abnormal laboratory results at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Run-in

Participants continue habitual lifestyle

1 week

1 visit (in-person)

Immobilization

Participants undergo 2 weeks of unilateral knee immobilization

2 weeks

2 visits (in-person)

Recovery

Participants return to habitual lifestyle

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Protein supplement
• Protein supplement with Urolithin A

Trial Overview The study tests if adding Urolithin A to a protein supplement helps maintain muscle health during periods when participants can't use their muscles due to wearing a knee brace. It compares the effects of just protein supplementation against protein with Urolithin A.

How Is the Trial Designed?

Group I: Protein supplement with Urolithin A Experimental Treatment 1 Intervention

Group II: Protein supplement Active Control 1 Intervention

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9133463/

Urolithin A improves muscle strength, exercise ... The data show significant improvements in muscle strength (∼12%) with intake of Urolithin A. We observe clinically meaningful improvements with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10609777/

Pharmacological Effects of Urolithin A and Its Role in ... Urolithin A may have a positive impact on muscle hypertrophy and maintenance of muscle mass. It exerts its effects through multiple pathways, including ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788244

Effect of Urolithin A Supplementation on Muscle Endurance ... These findings indicate that urolithin A was safe and well tolerated as well as beneficial for muscle endurance and mitochondrial health in older adults.

4. medrxiv.org medrxiv.org/content/10.1101/2025.07.10.25331277.full

The effects of urolithin A supplementation on muscle ... Four of 12 included outcome measures showed a statistically significant positive effect of urolithin A on muscle strength and physical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05814705?intr=Urolithin%20A&rank=10

The Effects of Protein Supplementation With or Without ... Recent research suggests that Urolithin A, which is a natural compound that can be produced after eating pomegranates, nuts, and berries, improves muscle health ...