Exercise and Branched Chain Amino Acids (BCAA)Requirements in Older Men

January 9, 2016 updated by: Peter Lemon, University of Western Ontario, Canada

Can Branched Chained Amino Acid Supplementation Combined With Strength-Training Minimize Sarcopenia in Older Men?

Likely, branched chain amino acid (BCAA) requirements are increased in older strength-trained (ST) individuals. If so, supplementation in this group will maximize muscle protein synthesis (MPS) and minimize loss of muscle with age (sarcopenia).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We hypothesize that the dietary requirement for the branched chain amino acids (BCAA) in an older strength-trained (ST) population will be greater than the current recommendation (RDA). If so, a greater intake of BCAA together with ST is necessary if one aims to maximize muscle protein synthesis (MPS). Currently, the BCAA requirement in the ST older population (55-65 y) is unknown. This is critical information especially given the value of ST for overall health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5B9
        • Exercise Nutrition Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Recreationally active (~2-3 h/wk of physical activity) healthy older men (55-65 y)
  • A minimum of 4 month weight training experience

Exclusion Criteria:

  • Have symptoms or take medication for respiratory disease
  • Have symptoms or take medication for cardiovascular disease
  • Have symptoms or take medication for metabolic disease
  • Have symptoms or take mediation for neuromuscular disease
  • Use heart rate or blood pressure medications
  • Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
  • Have an excessive alcohol intake (more than 2 drinks per day)
  • Have any cardiovascular or neuromuscular limitations to exercise
  • Are allergic to milk or milk products
  • Use anabolic steroids or performance enhancing drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Branched chain amino acid
Branched chain amino acid as food supplement
Dietary supplement: Branched chain amino acid
seven graded intakes of a BCAA (branched chain amino acid) mixture from 50 to 350 mg.kg-1.d-1 will be used to measure BCAA requirement
Other Names:
  • Ajinomoto branched chain amino acids
Behavioral: Strength training
Strength training will include a split-training program using all major muscle groups of the body on a three day "on", one day "off" protocol. Muscle areas targeted on each training day will be as follows: Day1: chest, shoulder, triceps; Day2: back, biceps; Day3: legs and calfs; Day4: will be a rest day. On Day5: this cycle will begin again. A combination of free weights and machines will be used for each training day. Progressive overload protocol will be applied where the load used by every participant will be adjusted bi-weekly based on their 70% of 1 repetition maximum (maximum weight that can be lifted only one time). Instruction will be provided for all exercises and professional trainers will oversee all training sessions.
Other Names:
  • weight training
ACTIVE_COMPARATOR: Weight training
Strength training will include a split-training program using all major muscle groups of the body on a three day "on", one day "off" protocol. Muscle areas targeted on each training day will be as follows: Day1: chest, shoulder, triceps; Day2: back, biceps; Day3: legs and calfs; Day4: will be a rest day. On Day5: this cycle will begin again. A combination of free weights and machines will be used for each training day. Progressive overload protocol will be applied where the load used by every participant will be adjusted bi-weekly based on their 70% of 1RM (repetition maximum). Instruction will be provided for all exercises and professional trainers will oversee all training sessions.
Dietary supplement: Branched chain amino acid
seven graded intakes of a BCAA (branched chain amino acid) mixture from 50 to 350 mg.kg-1.d-1 will be used to measure BCAA requirement
Other Names:
  • Ajinomoto branched chain amino acids
Behavioral: Strength training
Strength training will include a split-training program using all major muscle groups of the body on a three day "on", one day "off" protocol. Muscle areas targeted on each training day will be as follows: Day1: chest, shoulder, triceps; Day2: back, biceps; Day3: legs and calfs; Day4: will be a rest day. On Day5: this cycle will begin again. A combination of free weights and machines will be used for each training day. Progressive overload protocol will be applied where the load used by every participant will be adjusted bi-weekly based on their 70% of 1 repetition maximum (maximum weight that can be lifted only one time). Instruction will be provided for all exercises and professional trainers will oversee all training sessions.
Other Names:
  • weight training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Required Branched chain amino acid of older strength trained men
Time Frame: 12 months
Branched chain amino acid requirement will be measured in 55-65 years old strength trained men using indicator amino acid oxidation method
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle size
Time Frame: 12 months
cross-sectional measure of muscle size will be measured in all participants using standard procedures of magenetic resonance imaging
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Western Ontario, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Lemon, PhD, The University of Western Ontario
  • Study Director: Arash Bandegan, MSc., The University of Western Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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