Loading clinical trials...

COMPLETEDNA

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

NCT03267745•McMaster University

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

Age

20 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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;
+7 more criteria

Locations (1)

McMaster Univeristy

Hamilton, Ontario, Canada

Key Dates

Start Date

August 30, 2017

Primary Completion Date

December 19, 2017

Completion Date

August 1, 2018

Last Updated

June 19, 2019

Enrollment

ACTUAL participants

Conditions

Muscle Atrophy

Interventions

Amino Acid

DIETARY_SUPPLEMENT

Breg Brace single-leg immobilization

DEVICE

Placebo

OTHER

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

NCT05627440

Heart FailureMuscle Atrophy

View study

RECRUITINGNA

FIT Exercise in 30d of ULLS-induced Muscle Disuse

NCT06631053

Muscle AtrophyMuscle Weakness

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

FIT Exercise in 30d of ULLS-induced Muscle Disuse

The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty

Vitamin D to Improve Quadricep Muscle Strength

The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease