Dose and Response of Dietary Nitrate in Healthy and Active Men

Healthy Clinical Trial

Official title:

Dose and Response of Dietary and Inorganic Nitrate in Healthy and Active Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961427
• Other study ID #: 2013-12
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: November 18, 2016
• Start date: June 2013
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement.

It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate.

Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at different time points and the subjects have to perform an exercise test measuring oxygen consumption 3 hours after the ingestion of nitrate.

Description:

1. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure nitrate and nitrite concentration in the blood.

2. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Three hours after the intake of the supplement the subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50% of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood withdrawal is taken before the ingestion, after 3 hours and after the test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age 18 to 45

• healthy active men

• non-smoking

Exclusion Criteria:

• medication intake during study phase

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• sodium nitrate
Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
• Beetroot juice
concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen consumption	Oxygen consumption during exercise protocol	30min	No
Secondary	Blood pressure	every hour, blood pressure is measured.	6 hours	No
Secondary	oxygen saturation	every hour oxygen saturation is measured.	6 hours	No
Secondary	Rating of perceived exertion (RPE)	RPE is measured after the low-intensity exercise performance and after the submaximal exercise performance.	during the 7 weeks of study phase	No
Secondary	Heart rate	Heart rate is measured before the ingestion, before the exercise test and during the exercise test. resting heart rate is additionally measured every hours after the intake of dietary/inorganic nitrate.	during the 7 weeks of study phase	No
Secondary	Nitrate and nitrite concentration	every hour for the six hours after the ingestion of dietary/inorganic nitrate, nitrate and nitrite concentration in the blood is analyzed.	6 hours	No