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Completed

NCT Number: NCT02271633

Nitrate Supplementation; Source

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

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Key information

Conditions

Blood Pressure Nutritional Physiological Phenomena

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Centre+

Maastricht, Limburg, 6200MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium nitrate

Dietary Supplement

Beetroot juice

Dietary Supplement

Spinach

Dietary Supplement

Rocket salad

Dietary Supplement

Primary outcomes

  1. Plasma nitrite levels

    Time frame: Baseline until 5 hours after ingestion

    Plasma nitrite levels following ingestion of dietary nitrate

Secondary outcomes

  1. Plasma levels of nitrate

    Time frame: Baseline until 5 hours post-ingestion

    Plasma nitrate levels following ingestion of dietary nitrate

  2. Resting blood pressure

    Time frame: Baseline, 2.5 hours and 5 hours post-ingestion

    Resting blood pressure measures following ingestion of dietary nitrate

  3. Tongue scraping to assess bacterial mouth flora.

    Time frame: 5 h post-ingestion

    Tongue scraping to assess bacterial mouth flora.

Other outcomes

  1. Baseline characteristics

    Time frame: 1 hour during visit 1 (Screening)

    Resting blood pressure, height, body weight, age, BMI

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Nitrate Supplementation: Source of Supplementation

Acronym: NO-what

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Oct 22, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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