Impact of Varying Doses of Amino Acids on Exercise, Muscular and Mental Performance

November 1, 2010 updated by: McMaster University

A number of studies have shown that ingestion of crystalline amino acids, in particular branched chain amino acids (BCAA) can affect endurance performance, markers of muscle damage, and possibly mental focus. It seems that the longer and lower intensity events are affected more by consumption of BCAA. This study will test the hypothesis that BCAA availability limits central fatigue (the feeling of tiredness). While various aspects of performance have been tested no study to date has tested multiple exercise, muscular, and mental performance aspects in a single study. Thus, the overall purpose of this study is to determine whether an amino acid supplement changes the mental and physical response to prolonged exercise versus a placebo (carbohydrate drink).

This nutritional supplement could be useful on two levels. Improved mental focus and endurance performance and decreased central fatigue and muscle soreness could be valuable for enhancing athlete performance. Similarly, decreased central fatigue and muscle soreness may increase the willingness of the general public to exercise which could translate into decreased health risks and increased health benefits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific Purpose and Hypotheses

In the current proposal we outline a study that will examine a comprehensive battery of tests to assess the efficacy of Amino Vital's Amino Acid (AA) formulation to improve physical and mental performance after exercise.

We hypothesize:

  1. Ingestion of the Amino Acid (AA) formula will improve cognitive, motor, and physical performance on the post-exercise tasks in a hierarchical manner: 2AA > AA > placebo
  2. Blood concentrations of amino acids will be higher in the AA trials in a hierarchical manner: 2AA >AA > placebo
  3. Markers of muscle damage will be lower than placebo in a hierarchical manner: placebo > AA > 2AA

Recruitment Methods and Process Recruitment methods will be passive. Participants will be made aware of the study through the use of Hamilton Health Science/Faculty of Health Sciences Research Ethics Board (HHS/FHS REB) approved posted flyers at McMaster University and will voluntarily initiate contact with the study team. A recruitment poster will also be submitted for posting on the McMaster Daily News webpage.

Research Design and Methodology This study will use a double-blind repeated measures study design in which subjects will complete 7 sessions. The sessions consist of familiarization and the completion of three trials (placebo, AA, 2AA of AminoVital's formulation). Trials will be completed in a randomized, counterbalanced and blocked fashion such that with 12 subjects, 2 participants complete each trial order: ABC, ACB, BCA, BAC, CAB, CBA.

In the first session, participants will be screened using a standard health questionnaire. Interested participants will sign a consent form. They will then undergo testing of maximal oxygen consumption (VO2peak) using a treadmill. Subjects will also familiarize themselves with the physical and mental performance tests: Stroop test, profile of mood states (POMS), isometric strength test and an isokinetic muscle fatigue test. Following this initial session, participants will complete 3 trials (placebo, AA or 2AA drink formula) in random order.

On the first day of a trial, participants will arrive at the lab in the morning after a day of dietary control and a standardized breakfast including the treatment beverage. Prior to beginning exercise, participants will complete the physical and mental performance tests. A small catheter (flexible plastic tube) will be inserted into a forearm vein by Dr. Phillips or a medically trained and qualified member of the laboratory group; Dr. Tarnopolsky is responsible for the individuals inserting the venous catheters. The needle will be removed promptly after the insertion of each catheter; only the catheters will remain in their arms until the end of the trial. The catheter will be used for repeated blood sampling over the next six hours (see Figure 1). Additionally, breath samples will be taken at the same time as the blood samples. Following the performance tests, and prior to the start of exercise, a baseline blood sample will be drawn. Participants will then perform a bout of endurance exercise that consists of treadmill walking for 180 minutes at 40% of their peak VO2. Following the start of exercise, participants will consume a treatment beverage (or placebo) every 20 minutes after the start of exercise and continuing until 20 minutes after exercise (see Figure 1). Following the exercise bout, participants will repeat the physical and mental performance tests.

On the second day of a trial, participants will arrive after having consumed a standard breakfast including the treatment beverage. They will complete the physical and mental performance tests and one blood sample (4 mL) will be taken.

The trial day breakfast will consist of energy estimated for each subject based on the Harris-Benedict equation with an activity factor of 30%. The diet will be 55:30:15 in terms of percent energy from carbohydrate:fat:protein. Subjects will consume the same diet on the days prior to each exercise trial to control for pre-study calorie and carbohydrate/fat intake, which could affect substrate oxidation. Subjects will refrain from consumption of alcohol and caffeine on the day of the trial. Trials will take place at least 5d (but no more than 10d) apart and will commence at a time between ~6-10am and will proceed according to the schematic timeline shown in figure 1. The testing time for subjects will remain consistent throughout the study. We also believe that it is prudent for subjects to consume a fixed and constant volume of water (500 ml with breakfast) during all trials to prevent dehydration and to allow subjects to complete the exercise in safe manner.

Data Analyses/Statistics All data will be analyzed using a repeated measures two-way analysis of variance with time as a within factor and dose as a between factor. Significant ANOVA effects will be further scrutinized using Tukey's test as a post-hoc procedure. Where significant correlation of one variable with another exists, an analysis of covariance may also be performed. Significance will be accepted at P<0.05.

Instrumentation Sample analysis will be carried out using a microplate reader/ELISA for creatine kinase (CK), C-reactive protein (CRP), lactate dehydrogenase (LDH) and myoglobin, glucose and lactate auto-analyzers, High Performance Liquid Chromatography (HPLC) for amino acids as well as a metabolic cart gas analyzer to analyze breath samples.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

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
      • Hamilton, Ontario, Canada, L8S4K1
        • McMaster University

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

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Aged 18 to 30 years old
  • Non-obese (body mass index ≤ 30 kg/m2)
  • Non-smoker
  • Healthy (see exclusion criteria below)

Exclusion Criteria:

  • Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through medical history screening questionnaire.
  • Arthritic conditions
  • Individuals who cannot refrain from consuming any alcoholic beverages during the study
  • Individuals who chronically consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription
  • A history of neuromuscular problems
  • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Carbohydrate Placebo
Dietary supplement: AminoVital Amino Acid formulation
Contains minerals, vitamin C, flavour and sweetener.
Active Comparator: Single Dose

The Amino Vital Focus Zone is a dietary supplement of amino acid mixture, which also contains some minerals, vitamin C, flavour, and sweetener, and its appearance is clear to slightly opaque powder. The Amino Vital Focus Zone contains the five kind of amino acid (L-Leucine, L-Isoleucine, L-Valine, L-Arginine, and L-Glutamine), Citric acid, Vitamin C, some mineral, and sweetener.

Powdered treatments will be dissolved in water and administered orally. This treatment will contain 0.96 g of amino acids.
Dietary supplement: Amino Vital Amino Acid formulation
Contains minerals, vitamin C, flavour and sweetener and an amino acid mixture (2.4g of AA as: leucine, isoleucine, valine, arginine and glutamine).
Dietary supplement: Amino Vital Amino Acid formulation
Contains minerals, vitamin C, flavour and sweetener and a double dose of the amino acid mixture (4.8 g of AA as: leucine, isoleucine, valine, arginine and glutamine).
Active Comparator: Double Dose

The Amino Vital Focus Zone is a dietary supplement of amino acid mixture, which also contains some minerals, vitamin C, flavour, and sweetener, and its appearance is clear to slightly opaque powder. The Amino Vital Focus Zone contains the five kind of amino acid (L-Leucine, L-Isoleucine, L-Valine, L-Arginine, and L-Glutamine), Citric acid, Vitamin C, some mineral, and sweetener.

Powdered treatments will be dissolved in water and administered orally. This treatment will contain 1.92 g of amino acids.
Dietary supplement: Amino Vital Amino Acid formulation
Contains minerals, vitamin C, flavour and sweetener and an amino acid mixture (2.4g of AA as: leucine, isoleucine, valine, arginine and glutamine).
Dietary supplement: Amino Vital Amino Acid formulation
Contains minerals, vitamin C, flavour and sweetener and a double dose of the amino acid mixture (4.8 g of AA as: leucine, isoleucine, valine, arginine and glutamine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isometric strength test
Time Frame: Two Months
Measured on a Biodex leg extension machine. Subjects performed a 5 second voluntary maximal isometric contraction and peak torque was measured.
Two Months
Stroop Test
Time Frame: Two months
The Stroop test is a neuropsychological test to discern the subject's reaction time and cognitive processing speed. Subjects completed four subtasks in this test consisting of vocalizing the colour of boxes; random words; congruent word and colour; and incongruent word and colour.
Two months
Wing-Kristofferson Two-Model Test
Time Frame: Two months
Subjects will tap their index finger to the beat of a metronome for 10 seconds (synchronization). The metronome will be stopped and the subject will continue tapping for 20 seconds (continuation).
Two months
Muscle Damage Markers
Time Frame: Two months
Measurement of serum concentrations of creatine kinase (CK), lactate dehydrogenase (LDH), myoglobin, C-reactive protein (CRP).
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose and Lactate
Time Frame: Two months
Blood glucose was measured by glucose meter from a blood plasma sample. Blood lactate was measured from blood samples aliquoted into perchloric acid. The same is then neutralized and an assay kit is used to measure the lactate concentration.
Two months
Plasma amino acid concentrations
Time Frame: Two months
Using high-performance liquid chromatography, branched chain amino acid concentrations were measured from plasma samples.
Two months
Rating of Perceived Exertion
Time Frame: Two months
Using the Borg Scale, subjects were asked to rate their perceived exertion or how hard they felt they were working on a scale from 6 to 20.
Two months

Collaborators and Investigators

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

Sponsor

McMaster University

Collaborators

Ajinomoto USA, INC.

Investigators

  • Principal Investigator: Stuart M Phillips, Ph.D, McMaster University

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

July 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 09-584

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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