Condition category
Not Applicable
Date applied
14/09/2016
Date assigned
14/12/2016
Last edited
14/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Resistance exercise involves using an external force (such as heavy weights) to cause the muscles to contract. Eating or drinking protein after resistance exercise stimulates the making of new muscle proteins (muscle protein synthesis). Branched chain amino acids (BCAA) are often suggested as the main part of protein responsible for the increased protein synthesis, but no study has directly examined this. The aim of this study is to find out whether consuming BCAA increases muscle protein synthesis after resistance exercise in trained, young adult males.

Who can participate?
Healthy men aged 18-45 who are experienced weight lifters

What does the study involve?
This study consists of two phases. For each phase, participants undertake two 8-hour studies at the School of Sport and Exercise Sciences at the University of Birmingham. Before the studies, participants’ body composition and the maximum weight they can lift with one leg are assessed. Participants complete an intense bout of resistance exercise. Following the exercise, in Phase I participants are randomly allocated to consume either a drink containing BCAA or a placebo (dummy) drink. In Phase II, participants are randomly allocated to consume either a carbohydrate drink or a drink containing both BCAA and carbohydrates. Muscle samples (biopsies) are collected from the quadriceps (thigh) and blood samples are taken from a hand vein to work out the rates of protein synthesis.

What are the possible benefits and risks of participating?
Participants will receive information about how their muscle changes after exercise. Participants may experience discomfort during the blood or tissue sampling.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
October 2009 to October 2011

Who is funding the study?
GlaxoSmithKline Nutritional Healthcare (UK)

Who is the main contact?
Dr Sarah Jackman

Trial website

Contact information

Type

Public

Primary contact

Dr Sarah Jackman

ORCID ID

http://orcid.org/0000-0003-2928-8266

Contact details

Sport and Health Sciences
College of Life and Environmental Sciences
University of Exeter
St Luke's Campus
Heavitree Road
Exeter
EX1 2LU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Branched-chain amino acid ingestion stimulates muscle myofibrillar protein synthesis following resistance exercise in humans

Acronym

Study hypothesis

Ingestion of only branched-chain amino acids (BCAA) will be sufficient for the stimulation of myofibrillar muscle protein synthesis (MPS) rates after resistance exercise in a fed state in trained, young adult males.

Ethics approval

National Research Ethics Service ethics board, 24/09/2009, ref: 09/H1211/77

Study design

Crossover double-blind intervention study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Resistance exercise

Intervention

This research project was performed in two phases. The design, all procedures, risks and analyses of each phase were the same between the two phases. The only difference was the substances that were ingested. For each phase, 10 healthy, weight trained males aged 18 - 45 (from gyms in the local area) undertook two ~8 hour trials that took place in the School of Sport and Exercise Sciences at the University of Birmingham. Prior to the experimental trials, the maximum weight that could be lifted with one leg and body composition were assessed. During the experimental trials, participants were infused with metabolic tracers, muscle biopsies were collected and blood samples taken to determine rates of protein synthesis. Each participant completed an intense bout of resistance exercise followed by three muscle biopsies. Muscle and blood samples were analyzed to determine the rates of muscle protein synthesis and the signalling mechanisms inside the muscle that lead to increased synthesis. Following the exercise, participants will be randomised to consume either a BCAA-containing solution or a placebo in Phase I. In Phase II, a carbohydrate control solution will be compared to BCAA plus carbohydrates. Thus, in each phase, the BCAA will be compared with the appropriate control.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Fractional synthetic rate (FSR), measured using gas combustion isotope ratio chromatography mass spectrometry (GCCIRMS) over the 4h period following drink ingestion.

Secondary outcome measures

1. Signalling proteins, measured using western blots
2. Amino acids in blood, measured using gas chromatography mass spectrometry (GCMS)
3. Tracers enrichment in muscle, measured using GCMS
4. Tracers enrichment in plasma, measured using GCMS
5. Insulin in serum, measured using enzyme-linked immunosorbent assay (ELISA)
6. Glucose in plasma, measured using automated analysers

Blood sample timepoints: -240, -145, -85, -25, 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 240 min
Muscle biopsy timepoints: 0, 60 and 240 min

Overall trial start date

01/10/2009

Overall trial end date

01/10/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male, aged 18-45 years
2. Healthy (no known metabolic disorder)
3. Experienced weight lifter for more than 6 months (at least 2 leg resistance training sessions per week)

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

Not simultaneously taking part in another scientific/clinical study

Recruitment start date

01/10/2009

Recruitment end date

01/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

GlaxoSmithKline Nutritional Healthcare

Sponsor details

GSK House
980 Great West Road
Brentford
Middlesex
London
TW8 9GS
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline Nutritional Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the study will be disseminated to the scientific community via publication in scientific journals (that will ideally be open access). Ideally, the results of the study will also be presented at scientific conferences. Furthermore, it is hoped that the results of the study will be disseminated to the public in a lay summary via various media outlets, and also individual data will be made available and communicated to study volunteers upon request.

IPD sharing plan
The datasets generated and/or analysed during the current study are available from Dr Sarah Jackman on reasonable request.

Intention to publish date

24/01/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes