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

NCT03267745 | Completed

• 1 other identifier: 3365
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Atrophy

Keywords

protein; skeletal muscle; immobilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in muscle strength

  day 0, day 8, day 15 and day 28

• Change in muscle size

  day 0, day 8, day 15 and day 28

Study Arms (2)

Amino Acid

EXPERIMENTAL

Subjects in this arm will receive amino acid supplementation (23.7g) 3 times daily for 28 days. Amino acids will be provided in powder form to be dissolved in 8oz of water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period.

Dietary Supplement: Amino Acid; Device: Breg Brace single-leg immobilization

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive placebo 3 times daily for 28 days. Placebo will consist of 23.7g of excipient-matched placebo in water. Participants will also undergo single-leg immobilization (Breg brace) for 7 days (days 8-15) during the 28 day study period.

Device: Breg Brace single-leg immobilization; Other: Placebo

Interventions

Amino Acid DIETARY_SUPPLEMENT

23.7 g amino acid 3 times daily for 28 days

Amino Acid

Breg Brace single-leg immobilization DEVICE

7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°.

Also known as: Breg brace

Amino Acid; Placebo

Placebo OTHER

Excipient-matched placebo 3 times daily for 28 days

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• McMaster University: lead
• Axcella Health, Inc: collaborator

Study Sites (1)

McMaster Univeristy

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (1)

• 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.

  PMID: 31355205 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Stuart M Phillips, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Sachets with the supplement will be blinded to the participant, and research assistants. Outcomes assessors will be blinded to condition as well.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 30, 2017
• Study Start: August 30, 2017
• Primary Completion: December 19, 2017
• Study Completion: August 1, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)