NCT02604927

Brief Summary

Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines. Previous studies from our group have shown that upper-body exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional supplements capable of increasing buffering capacity. In line with this, have shown that upper-body muscle groups benefit more from artificially induced alkalosis than lower-body muscle groups. Although β-alanine appears to be an interesting and potential ergogenic supplement for paralympians, no study to date has assessed its potential in wheelchair athletes.In this study, we will evaluate the effects of β-alanine supplementation on upper-body performance in wheelchair athletes.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

September 22, 2015

Last Update Submit

November 11, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Exercise performance (Time to exhaustion test)

    Time to exhaustion test performed on arm crank ergometer

    28 days

  • Muscle carnosine content before and after supplementation

    Assessed by muscle biopsy samples before performance tests

    28 days

Secondary Outcomes (3)

  • Muscle carnosine content in trained (deltoid) vs. untrained (vastus lateralis) muscles

    28 days

  • Blood pH.

    5 minutes after performance tests

  • Safety of beta-alanine supplementation measured by complete hemogram analysis

    28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

800 mg of dextrose, four times per day, during 28 days.

Dietary Supplement: Dextrose

Beta-alanine

EXPERIMENTAL

800 mg of beta-alanine, four times per day, during 28 days.

Dietary Supplement: Beta-alanine

Interventions

Beta-alanineDIETARY_SUPPLEMENT
Beta-alanine
DextroseDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Paralympian training for any exercise modality for at least one year;
  • A weekly training volume of 6 hours or more;
  • Have a spinal cord injury accompanied by loss of motor function in the lower limbs for at least one year;
  • Available for carrying out the experimental procedures.

You may not qualify if:

  • Use of creatine or beta-alanine for at least 3 and 6 months before the trial;
  • Cardiovascular or respiratory disease;
  • Clinical condition that result in malabsorption of nutrients;
  • Any other medical condition that prevents the realization of experimental procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education and Sports, University of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

beta-AlanineGlucose

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydrates

Central Study Contacts

Guilherme Artioli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 22, 2015

First Posted

November 16, 2015

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

September 1, 2017

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations