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 range
18 Years – 30 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.)