NCT01215396

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
Last Updated

November 2, 2010

Status Verified

June 1, 2010

Enrollment Period

3 months

First QC Date

October 5, 2010

Last Update Submit

November 1, 2010

Conditions

Keywords

Branched Chain Amino AcidsMental PerformanceMuscular PerformanceCentral Fatigue Theory

Outcome Measures

Primary Outcomes (4)

  • Isometric strength test

    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

    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

    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

    Measurement of serum concentrations of creatine kinase (CK), lactate dehydrogenase (LDH), myoglobin, C-reactive protein (CRP).

    Two months

Secondary Outcomes (3)

  • Blood Glucose and Lactate

    Two months

  • Plasma amino acid concentrations

    Two months

  • Rating of Perceived Exertion

    Two months

Study Arms (3)

Carbohydrate Placebo

PLACEBO COMPARATOR
Dietary Supplement: AminoVital Amino Acid formulation

Single Dose

ACTIVE COMPARATOR

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

Double Dose

ACTIVE COMPARATOR

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

Interventions

Contains minerals, vitamin C, flavour and sweetener.

Carbohydrate Placebo

Contains minerals, vitamin C, flavour and sweetener and an amino acid mixture (2.4g of AA as: leucine, isoleucine, valine, arginine and glutamine).

Single Dose

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (16)

  • Morgan RM, Parry AM, Arida RM, Matthews PM, Davies B, Castell LM. Effects of elevated plasma tryptophan on brain activation associated with the Stroop task. Psychopharmacology (Berl). 2007 Feb;190(3):383-9. doi: 10.1007/s00213-006-0609-7. Epub 2006 Dec 19.

  • Blomstrand E. A role for branched-chain amino acids in reducing central fatigue. J Nutr. 2006 Feb;136(2):544S-547S. doi: 10.1093/jn/136.2.544S.

  • Newsholme EA, Blomstrand E. Branched-chain amino acids and central fatigue. J Nutr. 2006 Jan;136(1 Suppl):274S-6S. doi: 10.1093/jn/136.1.274S.

  • Blomstrand E. Amino acids and central fatigue. Amino Acids. 2001;20(1):25-34. doi: 10.1007/s007260170063.

  • Hassmen P, Blomstrand E, Ekblom B, Newsholme EA. Branched-chain amino acid supplementation during 30-km competitive run: mood and cognitive performance. Nutrition. 1994 Sep-Oct;10(5):405-10.

  • Ohtani M, Maruyama K, Sugita M, Kobayashi K. Amino acid supplementation affects hematological and biochemical parameters in elite rugby players. Biosci Biotechnol Biochem. 2001 Sep;65(9):1970-6. doi: 10.1271/bbb.65.1970.

  • Negro M, Giardina S, Marzani B, Marzatico F. Branched-chain amino acid supplementation does not enhance athletic performance but affects muscle recovery and the immune system. J Sports Med Phys Fitness. 2008 Sep;48(3):347-51.

  • Shimomura Y, Yamamoto Y, Bajotto G, Sato J, Murakami T, Shimomura N, Kobayashi H, Mawatari K. Nutraceutical effects of branched-chain amino acids on skeletal muscle. J Nutr. 2006 Feb;136(2):529S-532S. doi: 10.1093/jn/136.2.529S.

  • Jeukendrup AE, Wallis GA. Measurement of substrate oxidation during exercise by means of gas exchange measurements. Int J Sports Med. 2005 Feb;26 Suppl 1:S28-37. doi: 10.1055/s-2004-830512.

  • Phillips SM, Green HJ, Tarnopolsky MA, Grant SM. Decreased glucose turnover after short-term training is unaccompanied by changes in muscle oxidative potential. Am J Physiol. 1995 Aug;269(2 Pt 1):E222-30. doi: 10.1152/ajpendo.1995.269.2.E222.

  • Phillips SM, Green HJ, Tarnopolsky MA, Grant SM. Increased clearance of lactate after short-term training in men. J Appl Physiol (1985). 1995 Dec;79(6):1862-9. doi: 10.1152/jappl.1995.79.6.1862.

  • Phillips SM, Green HJ, Tarnopolsky MA, Heigenhauser GJ, Grant SM. Progressive effect of endurance training on metabolic adaptations in working skeletal muscle. Am J Physiol. 1996 Feb;270(2 Pt 1):E265-72. doi: 10.1152/ajpendo.1996.270.2.E265.

  • Wilkinson SB, Tarnopolsky MA, Macdonald MJ, Macdonald JR, Armstrong D, Phillips SM. Consumption of fluid skim milk promotes greater muscle protein accretion after resistance exercise than does consumption of an isonitrogenous and isoenergetic soy-protein beverage. Am J Clin Nutr. 2007 Apr;85(4):1031-40. doi: 10.1093/ajcn/85.4.1031.

  • Nosaka K, Sacco P, Mawatari K. Effects of amino acid supplementation on muscle soreness and damage. Int J Sport Nutr Exerc Metab. 2006 Dec;16(6):620-35. doi: 10.1123/ijsnem.16.6.620.

  • Mittleman KD, Ricci MR, Bailey SP. Branched-chain amino acids prolong exercise during heat stress in men and women. Med Sci Sports Exerc. 1998 Jan;30(1):83-91. doi: 10.1097/00005768-199801000-00012.

  • Carvalho-Peixoto J, Alves RC, Cameron LC. Glutamine and carbohydrate supplements reduce ammonemia increase during endurance field exercise. Appl Physiol Nutr Metab. 2007 Dec;32(6):1186-90. doi: 10.1139/H07-091.

Study Officials

  • Stuart M Phillips, Ph.D

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 6, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 2, 2010

Record last verified: 2010-06

Locations