The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization

McMaster University

Status

Active, not recruiting

Conditions

Muscle Disuse Atrophy

Healthy

Treatments

Dietary Supplement: Protein supplement with Urolithin A

Dietary Supplement: Protein supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT05814705

13783

ISRCTN20052152 (Registry Identifier)

Details and patient eligibility

About

There are times in life when people cannot use their muscles, such as during illness or injury. Muscle and mitochondria (the 'energy factory' in cells) health decline very quickly when people cannot use their muscles, but certain foods can help reduce these declines. Recent research suggests that Urolithin A, which is a natural compound that can be produced after eating pomegranates, nuts, and berries, improves muscle health. In this study, the investigators aim to investigate if a protein beverage (standard care during disuse) with or without Urolithin A can reduce or prevent the loss of muscle health while wearing a knee brace (muscle disuse).

Full description

After participants provide informed consent to participate and are deemed eligible for the study (Day 0), participants will sequentially complete the three phases of this study:

RUN-IN phase: participants continue habitual lifestyle (Day 7-Day 14 [1 week])
IMMOBILIZATION phase: participants undergo 2 weeks of unilateral knee immobilization (Day 14-Day 28 [2 weeks])
RECOVERY phase: participants return to habitual lifestyle (Day 28-Day 35 [1 week])

Participants will consume their randomly assigned supplement daily during all three phases.

Enrollment

24 estimated patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men aged 18-30 years
Healthy, non-smoking
BMI between 20 and 30 kg/m^2
No orthopedic issues that would preclude participation in the knee bracing protocol
Not taking any medication or with any medical condition that, in the opinion of the investigators, would compromise the study outcome or the safety of the research participant
Provide informed consent
Understand COVID-19 risks and procedures for in person research and sign Information Letter: COVID-19 Risks and Procedures for In-Person Research at McMaster University

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
Clinically significant abnormal laboratory results at screening
Participation in a clinical research trial within 30 days before randomization
Allergy or sensitivity to study ingredients
Individuals who are cognitively impaired and/or who are unable to give informed consent
Any other condition that, in the opinion of the investigators, may adversely affect the subject's ability to complete the study or its measures or may pose a significant risk to the subject
Any cachexia-related condition or any genetic muscle diseases or disorders
Current gastrointestinal condition that could interfere with the study (e.g., IBS/IBD [irritable bowel syndrome/inflammatory bowel disease], diarrhea, acid reflux disease, dysphagia, etc.)
Excessive alcohol consumption (>21 units/week) and/or a smoker (cigarettes or vaping)
Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine, whey protein supplements, casein, branched-chain amino acids (BCAAs) or any other NHP [Natural Health Product], medication or supplement used for muscle strengthening/building within 45 days prior to screening
Contraindications to an MRI scan (metal implants, metal-based ink tattoo)