CClinicalTrials.gg
CompletedNCT02271633NO-whatUpdated Mar 16, 2016

Nitrate Supplementation; Source

A Phase 4 interventional study of Sodium nitrate and Beetroot juice in Blood Pressure and Nutritional Physiological Phenomena, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Blood Pressure
  • Nutritional Physiological Phenomena

Keywords

  • Nitrate
  • Bioavailability
  • Sports
03

In context

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Use of medication
  • Smoking
  • Currently supplementing diet with nitrate
  • Lactose intolerance
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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: Sodium nitrate · Dietary Supplement: Spinach · Dietary Supplement: Rocket salad

  • Active comparator
    Spinach

    Dietary supplement: 800 mg of nitrate in a spinach based beverage

    Dietary Supplement: Sodium nitrate · Dietary Supplement: Beetroot juice · Dietary Supplement: Rocket salad

  • Active comparator
    Rocket salad

    Dietary supplement: 800 mg of nitrate in a rocket salad based beverage

    Dietary Supplement: Sodium nitrate · Dietary Supplement: Beetroot juice · Dietary Supplement: Spinach

Interventions

  • Dietary supplementSodium nitrate
  • Dietary supplementBeetroot juice
  • Dietary supplementSpinach
  • Dietary supplementRocket salad
06

What researchers measure

Primary outcomes

  1. Plasma nitrite levels

    Plasma nitrite levels following ingestion of dietary nitrate

    Time frame: Baseline until 5 hours after ingestion

Secondary outcomes

  1. Plasma levels of nitrate

    Plasma nitrate levels following ingestion of dietary nitrate

    Time frame: Baseline until 5 hours post-ingestion

  2. Resting blood pressure

    Resting blood pressure measures following ingestion of dietary nitrate

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

  3. Tongue scraping to assess bacterial mouth flora.

    Tongue scraping to assess bacterial mouth flora.

    Time frame: 5 h post-ingestion

Other outcomes

  1. Baseline characteristics

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

    Time frame: 1 hour during visit 1 (Screening)

07

Study locations

1 site
  • Maastricht University Medical Centre+
    Maastricht, Limburg 6200MD, Netherlands
08

References and documents

Publications

  • 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. PubMed 23640589 ↗
  • van Velzen AG, Sips AJ, Schothorst RC, Lambers AC, Meulenbelt J. The oral bioavailability of nitrate from nitrate-rich vegetables in humans. Toxicol Lett. 2008 Oct 1;181(3):177-81. doi: 10.1016/j.toxlet.2008.07.019. Epub 2008 Aug 3. PubMed 18723086 ↗
  • Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14. PubMed 22414688 ↗
  • Liu AH, Bondonno CP, Croft KD, Puddey IB, Woodman RJ, Rich L, Ward NC, Vita JA, Hodgson JM. Effects of a nitrate-rich meal on arterial stiffness and blood pressure in healthy volunteers. Nitric Oxide. 2013 Nov 30;35:123-30. doi: 10.1016/j.niox.2013.10.001. Epub 2013 Oct 10. PubMed 24120618 ↗
  • 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. PubMed 22248502 ↗
  • Jonvik KL, Nyakayiru J, Pinckaers PJ, Senden JM, van Loon LJ, Verdijk LB. Nitrate-Rich Vegetables Increase Plasma Nitrate and Nitrite Concentrations and Lower Blood Pressure in Healthy Adults. J Nutr. 2016 May;146(5):986-93. doi: 10.3945/jn.116.229807. Epub 2016 Apr 13. PubMed 27075914 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02271633
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Oct 22, 2014
Start date
Sep 2014
Primary completion
Dec 2014
Completion
Mar 2016
Last update
Mar 16, 2016

Study contacts

Lex Verdijk, PhD
principal investigator · Maastricht University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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