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Nitrate Supplementation; Source (NO-what)

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ClinicalTrials.gov Identifier: NCT02271633
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Nutritional Physiological Phenomena Dietary Supplement: Sodium nitrate Dietary Supplement: Beetroot juice Dietary Supplement: Spinach Dietary Supplement: Rocket salad Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Nitrate Supplementation: Source of Supplementation
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Plasma nitrite levels [ Time Frame: Baseline until 5 hours after ingestion ]
    Plasma nitrite levels following ingestion of dietary nitrate


Secondary Outcome Measures :
  1. Plasma levels of nitrate [ Time Frame: Baseline until 5 hours post-ingestion ]
    Plasma nitrate levels following ingestion of dietary nitrate

  2. Resting blood pressure [ Time Frame: Baseline, 2.5 hours and 5 hours post-ingestion ]
    Resting blood pressure measures following ingestion of dietary nitrate

  3. Tongue scraping to assess bacterial mouth flora. [ Time Frame: 5 h post-ingestion ]
    Tongue scraping to assess bacterial mouth flora.


Other Outcome Measures:
  1. Baseline characteristics [ Time Frame: 1 hour during visit 1 (Screening) ]
    Resting blood pressure, height, body weight, age, BMI



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271633


Locations
Netherlands
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Lex Verdijk, PhD Maastricht University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02271633     History of Changes
Other Study ID Numbers: METC14-3-020
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: May 2015

Keywords provided by Maastricht University Medical Center:
Nitrate
Bioavailability
Sports