NCT02019316

Brief Summary

BioSteel Sports Drink (BSD), a proprietary blend of branched chain amino acids, taurine, and B vitamins, has increased its popularity among professional and amateur athletes. BioSteel claims that BSD attenuates muscular and mental fatigue, and enhances recovery when consumed before and during intense exercise. To date, the efficacy of BSD on attenuating muscular and mental fatigue, and enhancing recovery during repeated bouts of intense exercise is unknown. In a blind crossover study, participants will be subjected to sprint interval exercise followed by muscular and cognitive function testing under two conditions: BSD and isoenergetic control.

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
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

December 11, 2013

Last Update Submit

December 17, 2013

Conditions

Fatigue

Keywords

SupplementationPerformanceCognitive FunctionMuscular EnduranceBioSteelBCAABranched Chain Amino AcidsSprint Interval Exercise

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Muscular Power

    Wingate test: Will be conducted using a cycle ergometer which electronically measures power (average, peak and decline). Resistance will be equal to 10% of subject body mass in kg.

    Baseline and following each trial (1 day).

Secondary Outcomes (7)

  • Change from baseline in Executive Function via Modified Stroop Test

    Baseline and after each trial (1 day).

  • Change from baseline in anaerobic muscular power via Sitting Medicine Ball Toss

    Baseline and after each trial (1 day).

  • Change from baseline in anaerobic muscular power via Standing Long Jump

    Baseline and after each trial (1 day).

  • Change from baseline in anaerobic muscular power via Vertical Jump

    Baseline and after each trial (1 day).

  • Change from baseline in muscular endurance via Bench Press

    Baseline and after each trial (1 day).

  • +2 more secondary outcomes

Study Arms (2)

BioSteel Sports Drink

EXPERIMENTAL

Participants will ingest 500ml of BioSteel Sports Drink 3 times during an exercise session.

Dietary Supplement: BioSteel Sports Drink

Isoenergetic Control

PLACEBO COMPARATOR

Participants will orally ingest 500ml of Isoenergetic Control (0.18 calories/kg body weight) 2 times separated by 60 minutes.

Dietary Supplement: Isoenergetic Control

Interventions

BioSteel Sports DrinkDIETARY_SUPPLEMENT

Participants will ingest 500ml of BioSteel Sports Drink 3 times during an exercise session.

Also known as: BioSteel
BioSteel Sports Drink
Isoenergetic ControlDIETARY_SUPPLEMENT

Participants will ingest 500ml of Gatorade 3 times during an exercise session.

Also known as: Gatorade
Isoenergetic Control

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, exercise-trained males aged 18-35 years. Participants can not have consumed BioSteel Sports Drink before. To ensure participants are highly trained, they must achieve the 2013 National Hockey League Combine average scores or better on 5 exercise tests (150 lb bench press, 8 lb sitting medicine ball toss, standing long jump, vertical jump and maximal oxygen consumption test on cycle ergometer). Women will be studied subsequently to asses andy gender differences.

You may not qualify if:

  • Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease.
  • Been diagnosed with a cognitive impairment and/or learning disability
  • Injury limiting exercise ability
  • Use of any medications with side effects of dizziness, lack of motor control, or slowed reaction time
  • Use of any other dietary supplements (excluding protein powder)
  • History of concussion/head injuries
  • Have an excessive alcohol intake (\>2 drinks/day)
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3M CTR - Rm 2235

London, Ontario, N6A 3K7, Canada

Location

Related Publications (8)

  • Greer BK, White JP, Arguello EM, Haymes EM. Branched-chain amino acid supplementation lowers perceived exertion but does not affect performance in untrained males. J Strength Cond Res. 2011 Feb;25(2):539-44. doi: 10.1519/JSC.0b013e3181bf443a.

    PMID: 20386134RESULT

  • Madsen K, MacLean DA, Kiens B, Christensen D. Effects of glucose, glucose plus branched-chain amino acids, or placebo on bike performance over 100 km. J Appl Physiol (1985). 1996 Dec;81(6):2644-50. doi: 10.1152/jappl.1996.81.6.2644.

    PMID: 9018517RESULT

  • van Hall G, Raaymakers JS, Saris WH, Wagenmakers AJ. Ingestion of branched-chain amino acids and tryptophan during sustained exercise in man: failure to affect performance. J Physiol. 1995 Aug 1;486 ( Pt 3)(Pt 3):789-94. doi: 10.1113/jphysiol.1995.sp020854.

    PMID: 7473239RESULT

  • Watson P, Shirreffs SM, Maughan RJ. The effect of acute branched-chain amino acid supplementation on prolonged exercise capacity in a warm environment. Eur J Appl Physiol. 2004 Dec;93(3):306-14. doi: 10.1007/s00421-004-1206-2.

    PMID: 15349784RESULT

  • Yatabe Y, Miyakawa S, Miyazaki T, Matsuzaki Y, Ochiai N. Effects of taurine administration in rat skeletal muscles on exercise. J Orthop Sci. 2003;8(3):415-9. doi: 10.1007/s10776-002-0636-1.

    PMID: 12768487RESULT

  • Blomstrand E, Hassmen P, Ekblom B, Newsholme EA. Administration of branched-chain amino acids during sustained exercise--effects on performance and on plasma concentration of some amino acids. Eur J Appl Physiol Occup Physiol. 1991;63(2):83-8. doi: 10.1007/BF00235174.

    PMID: 1748109RESULT

  • Blomstrand E, Hassmen P, Ek S, Ekblom B, Newsholme EA. Influence of ingesting a solution of branched-chain amino acids on perceived exertion during exercise. Acta Physiol Scand. 1997 Jan;159(1):41-9. doi: 10.1046/j.1365-201X.1997.547327000.x.

    PMID: 9124069RESULT

  • Noble BJ, Borg GA, Jacobs I, Ceci R, Kaiser P. A category-ratio perceived exertion scale: relationship to blood and muscle lactates and heart rate. Med Sci Sports Exerc. 1983;15(6):523-8.

    PMID: 6656563RESULT

MeSH Terms

Conditions

Fatigue

Interventions

gatorade

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter WR Lemon, Ph.D

    Western University, Canada

    PRINCIPAL INVESTIGATOR

  • Kolten C Abbott, B.Sc.

    Western University, Canada

    STUDY DIRECTOR

Central Study Contacts

Peter WR Lemon, Ph.D.

CONTACT

519-661-2111plemon@uwo.ca

Kolten C. Abbott, B.Sc.

CONTACT

519-661-2111kabbot3@uwo.ca

Study Design

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

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 24, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

CA(1)