Nitrate for High Intensity Intermittent Exercise (NITR-ITE)

July 5, 2016 updated by: Maastricht University Medical Center

The Effect of Nitrate Supplementation on Sport Performance: High Intensity Intermittent Performance in Recreational Athletes

The objective of the current study is to assess the effect of 6-day dietary nitrate ingestion on high intensity intermittent sports performance in recreational soccer players.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and concentrated red beetroot juice has been shown to significantly lower blood pressure at rest and to improve exercise performance during cycle time trials. Furthermore, a positive exercise performance effect of nitrate ingestion has been observed in recreational athletes during intermittent exercise. However, this was achieved after acute supplementation with a substantial dose of dietary nitrate. Whether similar ergogenic effects of nitrate supplementation can be achieved with a more conventional 6-day nitrate supplementation protocol with a lower daily dose remains to be established. Based on the gaps in current literature, our main goal will be to gain further insight into the effects of a 6-day nitrate supplementation protocol on high intensity intermittent exercise performance in recreational athletes.

Study Type

Interventional

Enrollment (Actual)

40

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+

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy P
  • Players of the first two senior selection teams of a regional soccer club competing at the 3rd KNVB level or higher
  • Training ≥2 days a week
  • 18-40 years
  • Male

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate-rich concentrated beetroot juice
Dietary supplement: 800 mg of nitrate in 140 mL of concentrated beetroot juice (Beet-IT)
Dietary supplement: Nitrate-rich concentrated beetroot juice
James White, Beet It Sport Shot, 70ml (Standard)
Placebo Comparator: Nitrate-depleted conc. beetroot juice
Placebo: 140 mL of nitrate-depleted concentrated red beetroot juice
Dietary supplement: Nitrate-depleted concentrated red beetroot juice
Beet It Sport Shot, 70ml (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total distance covered during the Yo-Yo Intermittent Recovery 1 test (Yo-Yo IR1 test)
Time Frame: Performance 3 hours post red beetroot juice ingestion
Performance 3 hours post red beetroot juice ingestion

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of nitrite and nitrate
Time Frame: Concetrations 3 hours post red beetroot juice ingestion
Concetrations 3 hours post red beetroot juice ingestion
Salivary concentration of nitrite and nitrate
Time Frame: Concetrations 3 hours post red beetroot juice ingestion
Concetrations 3 hours post red beetroot juice ingestion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics
Time Frame: 30 min during visit 1 (Screening)
Height, body weight, age, BMI
30 min 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

May 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • METC 153006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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