The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization (NCT05814705) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effects of Protein Supplementation With or Without Urolithin A During Single-leg Immobilization
Canada24 participantsStarted 2023-06-01
Plain-language summary
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).
Who can participate
Age range18 Years – 30 Years
SexMALE
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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
What they're measuring
1
Change in maximal mitochondrial respiration (rate of oxygen flux) and mitochondrial ADP [adenosine diphosphate] sensitivity (Oroboros O2k)
Timeframe: Outcome measured and reported for: Day 7, Day 14, Day 28, Day 35
✕. 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.)