Nitrate Supplementation; Source

NCT ID: NCT02271633

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Blood Pressure Nutritional Physiological Phenomena

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sodium nitrate

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

Group Type ACTIVE_COMPARATOR

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Spinach

Intervention Type DIETARY_SUPPLEMENT

Rocket salad

Intervention Type DIETARY_SUPPLEMENT

Beetroot juice

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

Group Type ACTIVE_COMPARATOR

Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Spinach

Intervention Type DIETARY_SUPPLEMENT

Rocket salad

Intervention Type DIETARY_SUPPLEMENT

Spinach

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

Group Type ACTIVE_COMPARATOR

Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Rocket salad

Intervention Type DIETARY_SUPPLEMENT

Rocket salad

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

Group Type ACTIVE_COMPARATOR

Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Spinach

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Spinach

Intervention Type DIETARY_SUPPLEMENT

Rocket salad

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lex Verdijk, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University Medical Centre+

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 23640589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18723086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22414688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24120618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22248502 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27075914 (View on PubMed)

Other Identifiers

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METC14-3-020

Identifier Type: -

Identifier Source: org_study_id

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