The effects of protein supplementation with or without Urolithin A during single-leg immobilizatio

Not Applicable

Completed

• Conditions: Disuse-induced muscle atrophy in healthy young adults; Musculoskeletal Diseases

• Registration Number: ISRCTN20052152
• Lead Sponsor: McMaster University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Study Completion: 2023-12-01
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1. Men aged 18-30 years
2. Healthy, non-smoking
3. BMI between 20 and 30 kg/m²
4. No orthopedic issues that would preclude participation in the knee bracing protocol
5. 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
6. Provide informed consent
7. 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

1. 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
2. Clinically significant abnormal laboratory results at screening
3. Participation in a clinical research trial within 30 days before randomization
4. Allergy or sensitivity to study ingredients
5. Individuals who are cognitively impaired and/or who are unable to give informed consent
6. 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
7. Any cachexia-related condition or any genetic muscle diseases or disorders
8. Current gastrointestinal condition that could interfere with the study (e.g., IBS/IBD, diarrhea, acid reflux disease, dysphagia, etc.)
9. Excessive alcohol consumption (>21 units/week) and/or a smoker (cigarettes or vaping)
10. Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine, whey protein supplements, casein, branched-chain amino acids (BCAAs) or any other NHP, medication or supplement used for muscle strengthening/building within 45 days prior to screening
11. Contraindications to an MRI scan (metal implants, metal-based ink tattoo)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Maximal mitochondrial respiration and mitochondrial ADP sensitivity (Oroboros O2k; measured at baseline and the end of each phase)<br>2. Gene expression (measured at baseline and the end of each phase)

Secondary Outcome Measures

Name	Time	Method
1. Skeletal muscle fractional synthetic rate (deuterated water; measured at baseline and the end of each phase)<br>2. Leg muscle strength (biodex dynamometer; measured at baseline and the end of each phase)<br>3. Quadriceps volume and cross-sectional area (magnetic resonance imaging; measured at baseline and the end of each phase)<br>4. Physical activity level (accelerometry; measured at baseline and the end of each phase)<br>5. Metabolomics (plasma; measured at baseline and the end of each phase)