NCT02115893

Brief Summary

The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

April 10, 2014

Last Update Submit

March 15, 2016

Conditions

Time-trial PerformanceSubmaximal Exercise PerformanceNitriteNitrate

Keywords

NitratePerformanceSports

Outcome Measures

Primary Outcomes (1)

  • Time-trial exercise performance

    The primary outcome measure will be the time to complete the time-trial following dietary nitrate or placebo ingestion

    Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)

Secondary Outcomes (4)

  • Resting blood pressure

    30 min pre-ingestion until 2.5 hours post-ingestion

  • Plasma nitrate and nitrite levels

    30 min pre-ingestion until 30 min post-time-trial testing

  • Submaximal exercise performance

    starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise

  • Time-trial exercise performance; power output and heart rate

    starting from 4 hours post-ingestion on testing days until completion of the time-trial

Other Outcomes (1)

  • Baseline characteristics and fitness level assessment

    3 hours during visit 1 (Screening)

Study Arms (2)

Sodium Nitrate

ACTIVE COMPARATOR

Dietary Supplement: Sodium nitrate 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany)

Dietary Supplement: Sodium Nitrate

Sodium Cloride

PLACEBO COMPARATOR

Dietary Supplement: Sodium chloride 800 mg of sodium chloride added with water to get a 140 mL solution (Frisia Zout BV, Harlingen, The Netherlands)

Dietary Supplement: Sodium Chloride

Interventions

Sodium NitrateDIETARY_SUPPLEMENT
Sodium Nitrate
Sodium ChlorideDIETARY_SUPPLEMENT
Sodium Cloride

Eligibility Criteria

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

You may qualify if:

  • \< BMI \< 25 kg/m2
  • Endurance trained cyclists/triathletes (with at least 1 year of competitive cycling experience)
  • VO2max ≥ 55 mL/kg/min

You may not qualify if:

  • Use of medication
  • Injury prohibiting them from performing the exercise protocol effectively
  • Smoking
  • Currently supplementing diet with nitrate
  • Lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Centre+

Maastricht, Limburg, 6200 MD, Netherlands

Location

Maastricht University Medical Centre+

Maastricht, Limburg, 6200MD, Netherlands

Location

Related Publications (3)

  • Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.

    PMID: 23640589BACKGROUND

  • Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64.

    PMID: 22248502BACKGROUND

  • Bescos R, Sureda A, Tur JA, Pons A. The effect of nitric-oxide-related supplements on human performance. Sports Med. 2012 Feb 1;42(2):99-117. doi: 10.2165/11596860-000000000-00000.

    PMID: 22260513BACKGROUND

MeSH Terms

Interventions

sodium nitrateSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Lex B Verdijk, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 16, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

March 1, 2015

Last Updated

March 16, 2016

Record last verified: 2014-10

Locations

NL(2)