Dose and Response of Dietary Nitrate in Healthy and Active Men

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01961427
First received: October 9, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: sodium nitrate
Dietary Supplement: Beetroot juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose and Response of Dietary and Inorganic Nitrate in Healthy and Active Men

Resource links provided by NLM:


Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • oxygen consumption [ Time Frame: 30min ] [ Designated as safety issue: No ]
    Oxygen consumption during exercise protocol


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    every hour, blood pressure is measured.

  • oxygen saturation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    every hour oxygen saturation is measured.

  • Rating of perceived exertion (RPE) [ Time Frame: during the 7 weeks of study phase ] [ Designated as safety issue: No ]
    RPE is measured after the low-intensity exercise performance and after the submaximal exercise performance.

  • Heart rate [ Time Frame: during the 7 weeks of study phase ] [ Designated as safety issue: No ]
    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.

  • Nitrate and nitrite concentration [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    every hour for the six hours after the ingestion of dietary/inorganic nitrate, nitrate and nitrite concentration in the blood is analyzed.


Estimated Enrollment: 21
Study Start Date: September 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sodium Nitrate 12mmol
Ingestion of a solution of inorganic nitrate, dosage: 12mmol
Dietary Supplement: sodium nitrate
Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
Other Name: Inorganic nitrate
Active Comparator: sodium Nitrate (6mmol)
ingestion of inorganic nitrate (6mmol solution)
Dietary Supplement: sodium nitrate
Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
Other Name: Inorganic nitrate
Active Comparator: sodium nitrate 3mmol
ingestion of inorganic nitrate (3mmol solution)
Dietary Supplement: sodium nitrate
Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
Other Name: Inorganic nitrate
Active Comparator: sodium nitrate (0mmol)
Ingestion of water as a placebo
Dietary Supplement: sodium nitrate
Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
Other Name: Inorganic nitrate
Active Comparator: Beetroot juice (12mmol)
ingestion of 170ml of concentrated beetroot juice (12mmol)
Dietary Supplement: Beetroot juice
concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)
Other Name: Biotta beetroot juice shot
Active Comparator: beetroot juice (6mmol)
ingestion of 85ml concentrated beetroot juice (6mmol)
Dietary Supplement: Beetroot juice
concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)
Other Name: Biotta beetroot juice shot
Active Comparator: Beetroot juice (3mmol)
Ingestion of 42.5ml of concentrated beetroot juice (3mmol)
Dietary Supplement: Beetroot juice
concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)
Other Name: Biotta beetroot juice shot

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 to 45
  • healthy active men
  • non-smoking

Exclusion Criteria:

  • medication intake during study phase
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961427

Locations
Switzerland
Swiss Paraplegic Centre
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
University of Zurich
Investigators
Principal Investigator: Claudio Perret, Dr. sc. nat. Sportmedizin Nottwil
  More Information

No publications provided

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01961427     History of Changes
Other Study ID Numbers: 2013‐12
Study First Received: October 9, 2013
Last Updated: May 21, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
dietary nitrate
beetroot juice
exercise performance
oxygen consumption

ClinicalTrials.gov processed this record on September 30, 2014