ISRCTN20052152Completed未知
Comparison of high-protein formulation with/without urolithin a during a unilateral knee immobilization: a pilot proof-of-concept trial
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
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)
Investigators
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