Modulation of Metabolic Rate by Inorganic Nitrate

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of sodium nitrate on resting metabolic rate, glucose uptake and formation of reactive oxygen species in humans.

Official Title
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Dietary Inorganic Nitrate: Effects on Metabolic Rate, Reactive Oxygen Species Production, Glucose Uptake and Primary Myotube Respiration.

Conditions
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Resting Metabolic Rate

Intervention / Treatment
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* Other: Glucose Uptake
* Other: Resting metabolic rate
* Other: Nitrite infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium nitrate<br>0.1 mmol NaNO3 / kg bodyweight / day for three days. | Other: Glucose Uptake<br>* Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp<br>Other: Resting metabolic rate<br>* Resting metabolic rate is measured by indirect calorimetry after an over-night fast<br>|
| Placebo Comparator: Sodium Chloride<br>0.1 mmol NaCl / kg bodyweight / day for three days. | Other: Glucose Uptake<br>* Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp<br>Other: Resting metabolic rate<br>* Resting metabolic rate is measured by indirect calorimetry after an over-night fast<br>|
| Active Comparator: Sodium nitrite infusion<br>Sodium nitrite (NaNO2) at a rate of 1, 10 and 100 nmol kg-1 min-1 (10 minutes per dose) was infused intravenously. | Other: Nitrite infusion<br>* Sodium nitrite or saline was infused at escalating doses at a rate of 1, 10 or 100 nmol kg-1 min-1 (10 minutes per dose) in a randomized, double blinded cross-over fashion<br>|
| Placebo Comparator: Saline infusion<br>Saline at a rate corresponding to 1, 10 and 100 nmol NaCl kg-1 min-1 (10 minutes per dose) was infused intravenously. | Other: Nitrite infusion<br>* Sodium nitrite or saline was infused at escalating doses at a rate of 1, 10 or 100 nmol kg-1 min-1 (10 minutes per dose) in a randomized, double blinded cross-over fashion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting metabolic rate | Resting metabolic rate, measured after overnight fast using indirect calorimetry | day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid hormone status |  | day 4 | 
| Glucose uptake | Glucose uptake measured with oral glucose tolerance test and euglycemic clamp | day 4 | 
| Nitrite infusion | Effect on resting metabolic rate when infusing escalating intravenous doses of sodium nitrite or saline solution | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric oxide, Nitrate, Nitrite, Resting metabolic rate, Glucose uptake, Insulin sensitivity, Reactive oxygen species production, inorganic nitrate, Sodium nitrite infusion