Status:
COMPLETED
Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Axcella Health, Inc
Conditions:
Muscle Atrophy
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.
Eligibility Criteria
Inclusion
- Generally healthy, non-smoking
- Willing and able to provide informed consent
- Men age 20-45 years
- BMI between 25 and 35 kg/m2
Exclusion
- Smoker;
- 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 illnesses which 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 units/week); (\> 21 standard drinks/wk); e.g., 18oz glass of 5% beer - 1.5 standard drinks, a 750 mL bottle of 12% wine = 5 standard drinks.
- Known sensitivity or allergy to amino acids or any ingredient in the test formulations;
- Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome;
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg 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;
- Contraindications to an MRI scan (e.g. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies, or subjects with claustrophobic symptoms that would contraindicate an MRI scan).
- Hemoglobin \<11.5mg/dl at Screening;
- Platelets \<150,000/uL (150x109/L) at Screening.
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03267745
Start Date
August 30 2017
End Date
August 1 2018
Last Update
June 19 2019
Active Locations (1)
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1
McMaster Univeristy
Hamilton, Ontario, Canada, L8S4K1