Influence of Dietary Nitrate on Time Trial Performance in... | NCT02454049

Studies
Influence of Dietary Nitrate on Time Trial Performance in Swiss Paracycling Athletes

NCT02454049

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Jan 18, 2019Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Exercise Nutritional Physiology

Interventions

beetroot juice
sodium nitrate
water

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Nov 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

May 21, 2015

First Posted Date

May 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2019

Last Update Posted Date

Jan 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The influence of dietary nitrate on performance will be tested performing a time trial on a handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects perform three trials and receive another supplement for each trial: beetroot juice with 6mmol nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the time trial will be the main outcome parameter.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
beetroot juice	Dietary Supplement	6mmol nitrate	beetroot juice
sodium nitrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to perform trial		3 hours after supplement ingestion

Secondary Outcomes

Measure	Description	Time Frame
oxygen consumption during time trial performance measured by a metabolic cart (Oxycon Pro) in ml/min/kg		3 hours after supplement ingestion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

female
smoking
any medication affecting performance
medical conditions affecting performance

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudio Perret, PD PhD	Swiss Paraplegic Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss Paraplegic Centre		Nottwil	Canton of Lucerne	6207	Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
C031618	sodium nitrate
D014867	Water

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided