Effect of Branched-chain Amino Acid Supplementation on Muscle Damage

• ClinicalTrials.gov Identifier: NCT03766815
• Recruitment Status: Unknown
• First Posted: December 6, 2018
• Last Update Posted: October 2, 2019
• Sponsor: Western University, Canada
• Information provided by (Responsible Party): Peter Lemon, Western University, Canada

Study Description

Brief Summary:

Seventy-eight recreational athletes who never resistance trained will be randomly assigned into three groups of twenty-six. Branched-chain amino acid will be supplemented for 18days at 0, 200 or 400 mg/body weight(kg)/day in jelly. Participants will be asked to perform elbow flexions on the 12th day of supplementation. Maximum voluntary contractions will be measured before, during and after the supplementation period to compare the effects of different doses of branched-chain amino acid has on muscle damage markers.

Condition or disease	Intervention/treatment	Phase
Muscle Damage	Dietary Supplement: BCAA 200mg/kg/day; Dietary Supplement: Placebo; Dietary Supplement: BCAA 400mg/kg/day; Behavioral: Muscle damaging exercise	Not Applicable

Detailed Description:

Previous studies have not been able to show consistent effects due to various reasons. The major limitations are the lack of enough data on the amount and duration of branched-chain amino acid supplementation, and the level of muscle damage for branched-chain amino acid to be effective. Based on a recent meta-analysis, it has been suggested that to be effective, branched-chain amino acid should be supplemented more than 200mg/kg/day before a low-to-moderate intensity exercise bout. Therefore, this study is designed based on the above suggestions and to compare the effect of different doses of branched-chain amino acid on muscle damage markers in healthy recreational active individuals.

Three treatment groups (n=26) will be randomly assigned to be supplemented with either 200mg BCAA/kg/day (BCAA200), 400mg BCAA/kg/day (BCAA400) or placebo (fiber supplement; PL). Supplements will be provided in jelly in a single blind fashion to be ingested 1hour after each of the three main daily meals for 18days. Anthropometric measurements (body weight, lean mass, height), body temperature, ultrasound (US), strength assessment (maximal voluntary contraction, MVC), resting metabolic rate (RMR), rate of perceived exertion (RPE), delayed onset of muscle soreness (DOMS) and blood samples (duplicates; myoglobin; BCAA) will be collected before, during and after the supplementation period at different time points (see appendix for the above tables). Repeated-bout effect (RBE) on both arms will be measured 7 days after the damage inducing session.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be supplemented for 18 days with either 200mg BCAA/kg/day, 400mg BCAA/kg/day or placebo (fiber supplement) in jelly in a single-blind fashion. Followed by a muscle damaging exercise and subsequent MVC and blood sample for force and metabolite measurements.
• Masking: Single (Participant)
• Masking Description: Participants will not be able to distinguish branched-chain amino acid and fiber supplement by taste, color or scent as the supplements are provided in jelly.
• Primary Purpose: Other
• Official Title: Effect of Branched-chain Amino Acid Supplementation on Muscle Damage in Recreational Athletes
• Estimated Study Start Date: October 1, 2019
• Estimated Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Fiber supplement mixed with jelly will be ingested for 18 days with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation.	Dietary Supplement: Placebo; Fiber supplement jelly for 18 days.; Behavioral: Muscle damaging exercise; Participants will be asked to perform muscle damaging elbow eccentric contraction exercise at 120% of 1RM for three sets of 15 repetitions with the dominant arm at maximal effort on a Biodex machine with a 3 minute rest period between each set.
Experimental: BCAA 200mg/kg/day; Branched-chain amino acid supplement mixed with jelly will be ingested for 18 days. The amount of supplement provided will be based on body weight (200mg/kg/day) with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation.	Dietary Supplement: BCAA 200mg/kg/day; BCAA supplement based on 200mg/kg/day for 18 days.; Behavioral: Muscle damaging exercise; Participants will be asked to perform muscle damaging elbow eccentric contraction exercise at 120% of 1RM for three sets of 15 repetitions with the dominant arm at maximal effort on a Biodex machine with a 3 minute rest period between each set.
Experimental: BCAA 400mg/kg/day; Branched-chain amino acid supplement mixed with jelly will be ingested for 18 days. The amount of supplement provided will be based on body weight (400mg/kg/day) with participants performing elbow eccentric contractions as a muscle damaging exercise on the 12th-day of supplementation.	Dietary Supplement: BCAA 400mg/kg/day; BCAA supplement based on 400mg/kg/day for 18 days.; Behavioral: Muscle damaging exercise; Participants will be asked to perform muscle damaging elbow eccentric contraction exercise at 120% of 1RM for three sets of 15 repetitions with the dominant arm at maximal effort on a Biodex machine with a 3 minute rest period between each set.

Outcome Measures

Primary Outcome Measures :

1. Change in maximum voluntary contraction (MVC) [ Time Frame: baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Participants will be asked to perform three repetitions of concentric elbow flexion at their maximal force (1RM) with both their dominant and non-dominant arm on an isokinetic dynamometer (Biodex).

Secondary Outcome Measures :

1. Change in blood myoglobin [ Time Frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Blood myoglobin will be measured with Enzyme-Linked Immunosorbent Assay.
2. Change in 3-methyl-histidine [ Time Frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Ultra-performance liquidchromatography tandem mass spectrometry (UPLC-MS/MS) using an Acquity Ultra Performance LC system coupled to a Waters Quattro Premier XE mass spectrometer (bothWaters Corporation, Milford, MA, USA) and the Waters MassLynx Software (Version 4.1).
3. Changes in insulin [ Time Frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Blood insulin will be measured with a standard insulin radioimmunoassay kit.
4. Change in muscle soreness [ Time Frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Perceived muscle soreness will be determined by asking participants to stand in the anatomical position while flexing the shoulder of the exercised arm at 90degrees and fully extending the elbow. Participants will be asked to determine their forearm flexor muscles soreness with the use of a visual analogue scale (VAS) and rate from 1 being no pain and 10 being extremely painful.
5. Change in ultrasound images of the arm muscles [ Time Frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Ultrasound measurements will be used to scan the triceps brachii and the forearm flexors. A permanent marker will be used to mark the elbow joint as the origin and both the belly of the triceps and the belly of the flexor digitorum profundus as the end point so as to compare the echoic difference in both the upper and lower arms.
6. Change in limb girth [ Time Frame: 10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Limb girth of the upper arm (between the lateral epicondyle of the humerus and the acromion process) and the lower arm (between the lateral epicondyle of the humerus and the styloid process of the radius) will be measured with an anthropometric tape when the arm is naturally hanging down.
7. Change in body temperature [ Time Frame: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Body temperature will be measured with an ear thermometer
8. Change in resting metabolic rate [ Time Frame: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Resting metabolic rate will be measured with a metabolic cart
9. Change in range of motion [ Time Frame: 20 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage ]
   Range of motion of the arm will be measured by asking the participant to stand in the anatomical position while fully flexing the shoulder of the exercised arm and then extending the elbow to an angle that they do not feel any pain in the arms. A goniometer will be used to measure the angles.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy males and females at the age of 18-40
• Endurance trained athletes
• Weekly exercise duration is less than 150minutes but more than 30 minutes

Exclusion Criteria:

• Individuals who cannot endure three days for not eating meat
• Diabetic
• Have been performing resistance trainings
• Have been taking protein supplement
• Have been consuming a high level of protein in the regular diet
• Have been taking omega-three and vitamin E supplements
• Have been taking anabolic Steroids
• Have been taking regular medications
• Have cardiovascular Disease
• Have a history of joint & Muscle Injuries
• Females with irregular Menstrual Cycle

Contacts and Locations

Contacts

Contact: Crystal Lee, BSc; 519 6612111; plee263@uwo.ca

Contact: Arash Bandegan, PhD; 519 6612111; abandeg@uwo.ca

Locations

Canada, Ontario

Exercise Nutrition Laboratory (Western University); Recruiting

London, Ontario, Canada, N6A 3K7

Contact: Peter Lemon, PhD 519 6612111 ext 88139 plemon@uwo.ca

Sponsors and Collaborators

Western University, Canada

Investigators

• Principal Investigator: Peter Lemon, PhD; Western University

More Information

• Responsible Party: Peter Lemon, Principal Investigator, Western University, Canada
• ClinicalTrials.gov Identifier: NCT03766815
• Other Study ID Numbers: 113281
• First Posted: December 6, 2018
• Last Update Posted: October 2, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes