Effect of a Natural Source Supplementation on Muscle Mass

This is an interventional basic science trial for Muscle Disuse Atrophy focused on measuring Skeletal muscle, Supplementation, Disuse, Single-leg immobilization Read More

Inclusion Criteria:

• Men, between the ages of 20-25 years (inclusive).
• Willing and able to provide informed consent.
• Be in general good health, non-smoking.
• Body mass index (BMI) between 20-35kg/m2.
• Agree to not consume eggs for the duration of the study.

Exclusion Criteria:

• Use of tobacco related products.
• Veganism or vegetarianism.
• Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the investigator, would compromise his/her ability to comply with the study requirements.
• History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
• Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder (requiring ongoing medical care), or metabolic/endocrine disorder (e.g. diabetes, high cholesterol, elevated fasting blood sugar) or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives.
• Any cachexia-related condition (e.g. relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders.
• Current illness with could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing).
• Subject participated in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study.
• Hypersensitivity to any of the components of the test product.
• Excessive alcohol consumption (>21 standard drinks/week, e.g. 18oz glass of 5% beer - 1.5 standard drinks, a 750ml bottle of 12% wine = 5 standard drinks).
• Known sensitivity or allergy to amino acids or any ingredient in the test formulations. 12) Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome.
• History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anti-coagulation therapy (up to 81 mg of baby aspirin per day taken as a prophylactic is permitted).
• Personal or family history of clotting disorder or deep vein thrombosis. Deep vein thrombosis is a serious, and potentially lethal, medical condition, therefore, it is imperative if you have personal or family history it is disclosed this to the research staff.
• Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to screening.