Nitrate Supplementation; Source (NO-what)

March 15, 2016 updated by: Maastricht University Medical Center

The Effect of Nitrate Supplementation: Source of Supplementation

The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oral ingestion of nitrate (NO3-) has been shown to increase plasma nitrate and nitrite levels. Significant lowering of pulmonary oxygen uptake during exercise, as well as significantly lower blood pressure values at rest have been observed after supplementation with nitrate. However, no study has yet described a direct comparison between different nitrate-rich beverages with respect to the bioavailability of nitrate/nitrite and the possible hemodynamic effects. Based on the gaps in current literature, our main goal will therefore be to gain further insight into the effects of nitrate supplementation with different sources on plasma nitrite levels.

Study Type

Interventional

Enrollment (Actual)

30

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18.5 < BMI < 30 kg/m2
  • Engagement in regular physical activity ( > 1 h a week)

Exclusion Criteria:

  • Use of medication
  • 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sodium nitrate
Dietary supplement: 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany)
Dietary supplement: Beetroot juice
Dietary supplement: Spinach
Dietary supplement: Rocket salad
ACTIVE_COMPARATOR: Beetroot juice
Dietary supplement: 800 mg of nitrate in concentrated beetroot juice (Beet-IT)
Dietary supplement: Spinach
Dietary supplement: Rocket salad
Dietary supplement: Sodium nitrate
ACTIVE_COMPARATOR: Spinach
Dietary supplement: 800 mg of nitrate in a spinach based beverage
Dietary supplement: Beetroot juice
Dietary supplement: Rocket salad
Dietary supplement: Sodium nitrate
ACTIVE_COMPARATOR: Rocket salad
Dietary supplement: 800 mg of nitrate in a rocket salad based beverage
Dietary supplement: Beetroot juice
Dietary supplement: Spinach
Dietary supplement: Sodium nitrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma nitrite levels
Time Frame: Baseline until 5 hours after ingestion
Plasma nitrite levels following ingestion of dietary nitrate
Baseline until 5 hours after ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma levels of nitrate
Time Frame: Baseline until 5 hours post-ingestion
Plasma nitrate levels following ingestion of dietary nitrate
Baseline until 5 hours post-ingestion
Resting blood pressure
Time Frame: Baseline, 2.5 hours and 5 hours post-ingestion
Resting blood pressure measures following ingestion of dietary nitrate
Baseline, 2.5 hours and 5 hours post-ingestion
Tongue scraping to assess bacterial mouth flora.
Time Frame: 5 h post-ingestion
Tongue scraping to assess bacterial mouth flora.
5 h post-ingestion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics
Time Frame: 1 hour during visit 1 (Screening)
Resting blood pressure, height, body weight, age, BMI
1 hour 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 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

September 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

October 13, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (ESTIMATE)

October 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • METC14-3-020

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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