NCT02271633

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

October 13, 2014

Last Update Submit

March 15, 2016

Conditions

Blood PressureNutritional Physiological Phenomena

Keywords

NitrateBioavailabilitySports

Outcome Measures

Primary Outcomes (1)

  • Plasma nitrite levels

    Plasma nitrite levels following ingestion of dietary nitrate

    Baseline until 5 hours after ingestion

Secondary Outcomes (3)

  • Plasma levels of nitrate

    Baseline until 5 hours post-ingestion

  • Resting blood pressure

    Baseline, 2.5 hours and 5 hours post-ingestion

  • Tongue scraping to assess bacterial mouth flora.

    5 h post-ingestion

Other Outcomes (1)

  • Baseline characteristics

    1 hour during visit 1 (Screening)

Study Arms (4)

Sodium nitrate

ACTIVE COMPARATOR

Dietary supplement: 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany)

Dietary Supplement: Beetroot juiceDietary Supplement: SpinachDietary Supplement: Rocket salad

Beetroot juice

ACTIVE COMPARATOR

Dietary supplement: 800 mg of nitrate in concentrated beetroot juice (Beet-IT)

Dietary Supplement: Sodium nitrateDietary Supplement: SpinachDietary Supplement: Rocket salad

Spinach

ACTIVE COMPARATOR

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

Dietary Supplement: Sodium nitrateDietary Supplement: Beetroot juiceDietary Supplement: Rocket salad

Rocket salad

ACTIVE COMPARATOR

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

Dietary Supplement: Sodium nitrateDietary Supplement: Beetroot juiceDietary Supplement: Spinach

Interventions

Sodium nitrateDIETARY_SUPPLEMENT
Beetroot juiceRocket saladSpinach
Beetroot juiceDIETARY_SUPPLEMENT
Rocket saladSodium nitrateSpinach
SpinachDIETARY_SUPPLEMENT
Beetroot juiceRocket saladSodium nitrate
Rocket saladDIETARY_SUPPLEMENT
Beetroot juiceSodium nitrateSpinach

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6200MD, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 23640589BACKGROUND

  • 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.

    PMID: 18723086BACKGROUND

  • 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.

    PMID: 22414688BACKGROUND

  • 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.

    PMID: 24120618BACKGROUND

  • 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.

    PMID: 22248502BACKGROUND

  • 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.

    PMID: 27075914DERIVED

MeSH Terms

Interventions

sodium nitrate

Study Officials

  • Lex Verdijk, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 22, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2016

Last Updated

March 16, 2016

Record last verified: 2015-05

Locations

NL(1)