Comparison of high-protein formulation with/without urolithin a during a unilateral knee immobilization: a pilot proof-of-concept trial

McMaster University0 个研究点目标入组 24 人开始时间: 2023年2月9日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•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

•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)

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