Clinical trial NCT03267745: Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization
Official title: Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Atrophy
Keywords: protein
skeletal muscle
immobilization
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Axcella Health, Inc
First posted: 2017-08-30
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of 10 each will be randomized to receive amino acid supplementation or placebo for 28 days during which they will have one leg immobilized by a removable brace.
Primary purpose: BASIC_SCIENCE

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 Criteria:

1. Generally healthy, non-smoking
2. Willing and able to provide informed consent
3. Men age 20-45 years
4. BMI between 25 and 35 kg/m2

Exclusion Criteria:

1. Smoker;
2. 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;
3. 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;
4. 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;
5. 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;
6. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing);
7. 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;
8. Hypersensitivity to any of the components of the test product;
9. 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.
10. Known sensitivity or allergy to amino acids or any ingredient in the test formulations;
11. Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome;
12. 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);
13. 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.
14. 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;
15. 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).
16. Hemoglobin \<11.5mg/dl at Screening;
17. Platelets \<150,000/uL (150x109/L) at Screening.

Primary outcomes:
measure: Change in muscle atrophy
timeFrame: day 0, day 8, day 15 and day 28
Secondary outcomes:
measure: Change in muscle strength
timeFrame: day 0, day 8, day 15 and day 28
measure: Change in muscle size
timeFrame: day 0, day 8, day 15 and day 28
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Univeristy
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart M Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holloway TM, McGlory C, McKellar S, Morgan A, Hamill M, Afeyan R, Comb W, Confer S, Zhao P, Hinton M, Kubassova O, Chakravarthy MV, Phillips SM. A Novel Amino Acid Composition Ameliorates Short-Term Muscle Disuse Atrophy in Healthy Young Men. Front Nutr. 2019 Jul 10;6:105. doi: 10.3389/fnut.2019.00105. eCollection 2019.