NCT03766815

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

December 3, 2018

Last Update Submit

September 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in maximum voluntary contraction (MVC)

    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).

    baseline (before supplementation) and at 1,3,24,48,72,96,120,144 hours after muscle damage

Secondary Outcomes (9)

  • Change in blood myoglobin

    10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage

  • Change in 3-methyl-histidine

    10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage

  • Changes in insulin

    10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage

  • Change in muscle soreness

    10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage

  • Change in ultrasound images of the arm muscles

    10 min before muscle damaging exercise and at each of 1,3,24,48,72,96,120,144 hours after muscle damage

  • +4 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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: PlaceboBehavioral: Muscle damaging exercise

BCAA 200mg/kg/day

EXPERIMENTAL

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/dayBehavioral: Muscle damaging exercise

BCAA 400mg/kg/day

EXPERIMENTAL

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/dayBehavioral: Muscle damaging exercise

Interventions

BCAA 200mg/kg/dayDIETARY_SUPPLEMENT

BCAA supplement based on 200mg/kg/day for 18 days.

BCAA 200mg/kg/day
PlaceboDIETARY_SUPPLEMENT

Fiber supplement jelly for 18 days.

Placebo
BCAA 400mg/kg/dayDIETARY_SUPPLEMENT

BCAA supplement based on 400mg/kg/day for 18 days.

BCAA 400mg/kg/day

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.

BCAA 200mg/kg/dayBCAA 400mg/kg/dayPlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

RECRUITING

Study Officials

  • Peter Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Lee, BSc

CONTACT

Arash Bandegan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 6, 2018

Study Start

October 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 2, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations