Dose and Response of Dietary Nitrate in Healthy and Active Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: sodium nitrate
* Dietary Supplement: Beetroot juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 45 healthy active men non-smoking Exclusion Criteria: medication intake during study phase

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium Nitrate 12mmol<br>Ingestion of a solution of inorganic nitrate, dosage: 12mmol | Dietary Supplement: sodium nitrate<br>* Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate<br>* Other names: Inorganic nitrate;|
| Active Comparator: sodium Nitrate (6mmol)<br>ingestion of inorganic nitrate (6mmol solution) | Dietary Supplement: sodium nitrate<br>* Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate<br>* Other names: Inorganic nitrate;|
| Active Comparator: sodium nitrate 3mmol<br>ingestion of inorganic nitrate (3mmol solution) | Dietary Supplement: sodium nitrate<br>* Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate<br>* Other names: Inorganic nitrate;|
| Active Comparator: sodium nitrate (0mmol)<br>Ingestion of water as a placebo | Dietary Supplement: sodium nitrate<br>* Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate<br>* Other names: Inorganic nitrate;|
| Active Comparator: Beetroot juice (12mmol)<br>ingestion of 170ml of concentrated beetroot juice (12mmol) | Dietary Supplement: Beetroot juice<br>* concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)<br>* Other names: Biotta beetroot juice shot;|
| Active Comparator: beetroot juice (6mmol)<br>ingestion of 85ml concentrated beetroot juice (6mmol) | Dietary Supplement: Beetroot juice<br>* concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)<br>* Other names: Biotta beetroot juice shot;|
| Active Comparator: Beetroot juice (3mmol)<br>Ingestion of 42.5ml of concentrated beetroot juice (3mmol) | Dietary Supplement: Beetroot juice<br>* concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)<br>* Other names: Biotta beetroot juice shot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen consumption | Oxygen consumption during exercise protocol | 30min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | every hour, blood pressure is measured. | 6 hours | 
| oxygen saturation | every hour oxygen saturation is measured. | 6 hours | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary nitrate, beetroot juice, exercise performance, oxygen consumption