Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization

Muscle Atrophy Clinical Trial

Official title:

Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267745
• Other study ID #: 3365
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: June 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2018
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Muscle Atrophy
• Muscular Atrophy

Intervention

Dietary Supplement:
• Amino Acid
23.7 g amino acid 3 times daily for 28 days

Device:
• Breg Brace single-leg immobilization
7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°.

Other:
• Placebo
Excipient-matched placebo 3 times daily for 28 days

Locations

Country	Name	City	State
Canada	McMaster Univeristy	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Axcella Health Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle atrophy	To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis.	day 0, day 8, day 15 and day 28
Secondary	Change in muscle strength	Strength will be measured using a Biodex.	day 0, day 8, day 15 and day 28
Secondary	Change in muscle size	Muscle size will be assessed via MRI.	day 0, day 8, day 15 and day 28