NCT02454049

Brief Summary

The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will be investigated in spinal cord injured and non-injured athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

May 19, 2015

Last Update Submit

January 17, 2019

Conditions

Exercise Nutritional Physiology

Outcome Measures

Primary Outcomes (1)

  • time to perform trial

    3 hours after supplement ingestion

Secondary Outcomes (1)

  • oxygen consumption during time trial performance measured by a metabolic cart (Oxycon Pro) in ml/min/kg

    3 hours after supplement ingestion

Study Arms (3)

beetroot juice

ACTIVE COMPARATOR

beetroot juice containing 6mmol nitrate, ingested 3hours before the exercise test

Dietary Supplement: beetroot juice

sodium nitrate

ACTIVE COMPARATOR

6mmol sodium nitrate dissolved in plain water, ingested 3hours before the exercise test

Dietary Supplement: sodium nitrate

water

PLACEBO COMPARATOR

85ml of plain water, ingested 3 hours before the exercise test

Dietary Supplement: water

Interventions

beetroot juiceDIETARY_SUPPLEMENT

6mmol nitrate

beetroot juice
sodium nitrateDIETARY_SUPPLEMENT

6mmol sodium nitrate

sodium nitrate
waterDIETARY_SUPPLEMENT

plain water

water

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy paracycling athletes
  • healthy, able-bodied, upper-body trained individuals

You may not qualify if:

  • female
  • smoking
  • any medication affecting performance
  • medical conditions affecting performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Interventions

sodium nitrateWater

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Claudio Perret, PD PhD

    Swiss Paraplegic Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 27, 2015

Study Start

September 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

CH(1)