Nitrate Supplementation; Source

Blood Pressure Clinical Trial

— NO-what  

Official title:

The Effect of Nitrate Supplementation: Source of Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271633
• Other study ID #: METC14-3-020
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2014
• Last updated: March 15, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure
• Nutritional Physiological Phenomena

Intervention

Dietary Supplement:
• Sodium nitrate

• Beetroot juice

• Spinach

• Rocket salad

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline characteristics	Resting blood pressure, height, body weight, age, BMI	1 hour during visit 1 (Screening)	No
Primary	Plasma nitrite levels	Plasma nitrite levels following ingestion of dietary nitrate	Baseline until 5 hours after ingestion	No
Secondary	Plasma levels of nitrate	Plasma nitrate levels following ingestion of dietary nitrate	Baseline until 5 hours post-ingestion	No
Secondary	Resting blood pressure	Resting blood pressure measures following ingestion of dietary nitrate	Baseline, 2.5 hours and 5 hours post-ingestion	No
Secondary	Tongue scraping to assess bacterial mouth flora.	Tongue scraping to assess bacterial mouth flora.	5 h post-ingestion	No