Nitrate Supplementation; Duration (NO-how)

March 15, 2016 updated by: Maastricht University Medical Center

The Effect of Nitrate Supplementation on Sports Performance: Duration of Supplementation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen uptake during exercise, in addition to improving exercise performance during cycle time trial. However, there has been no consensus on the optimal supplementation protocols, in terms of duration of supplementation to see these metabolic effects. Furthermore, a positive exercise performance effect of nitrate ingestion has primarily been observed in recreational athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes therefore remain to be fully established. Based on the gaps in current literature, our main goal will be to gain further insight into different aspects of nitrate supplementation to enhance (elite) sports performance. This will be investigated in this study by assessing the effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise performance.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200MD
        • Maastricht University Medical Centre+
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Centre+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium Nitrate
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
Placebo Comparator: Sodium Cloride
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-trial exercise performance
Time Frame: Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting blood pressure
Time Frame: 30 min pre-ingestion until 2.5 hours post-ingestion
Resting blood pressure measures following ingestion of dietary nitrate
30 min pre-ingestion until 2.5 hours post-ingestion
Plasma nitrate and nitrite levels
Time Frame: 30 min pre-ingestion until 30 min post-time-trial testing
Plasma nitrate and nitrite levels following ingestion of dietary nitrate
30 min pre-ingestion until 30 min post-time-trial testing
Submaximal exercise performance
Time Frame: starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise
Oxygen consumption CO2 production and heart rate during submaximal exercise
starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise
Time-trial exercise performance; power output and heart rate
Time Frame: starting from 4 hours post-ingestion on testing days until completion of the time-trial
Power output and heart rate during the time-trial exercise
starting from 4 hours post-ingestion on testing days until completion of the time-trial

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics and fitness level assessment
Time Frame: 3 hours during visit 1 (Screening)
Resting blood pressure, height, body weight, age, BMI, measures of GI tolerance, VO2 max, Wmax, rate of perceived exertion
3 hours during visit 1 (Screening)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Lex B Verdijk, PhD, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • METC13-3-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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