Clinical trial NCT02271633: Nitrate Supplementation; Source
Official title: The Effect of Nitrate Supplementation: Source of Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Nutritional Physiological Phenomena
Keywords: Nitrate
Bioavailability
Sports
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma nitrite levels
timeFrame: Baseline until 5 hours after ingestion
Secondary outcomes:
measure: Plasma levels of nitrate
timeFrame: Baseline until 5 hours post-ingestion
measure: Resting blood pressure
timeFrame: Baseline, 2.5 hours and 5 hours post-ingestion
measure: Tongue scraping to assess bacterial mouth flora.
timeFrame: 5 h post-ingestion
Other outcomes:
measure: Baseline characteristics
timeFrame: 1 hour during visit 1 (Screening)
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre+
state: Limburg
Study officials:
affiliation: Maastricht University
name: Lex Verdijk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.