Modulation of Metabolic Rate by Inorganic Nitrate

January 2, 2014 updated by: Eddie Weitzberg, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium nitrate
0.1 mmol NaNO3 / kg bodyweight / day for three days.
Other: Glucose Uptake
Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp
Other: Resting metabolic rate
Resting metabolic rate is measured by indirect calorimetry after an over-night fast
Placebo Comparator: Sodium Chloride
0.1 mmol NaCl / kg bodyweight / day for three days.
Other: Glucose Uptake
Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp
Other: Resting metabolic rate
Resting metabolic rate is measured by indirect calorimetry after an over-night fast
Active Comparator: Sodium nitrite infusion
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
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
Placebo Comparator: Saline infusion
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Swedish Heart Lung Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JETF-6996-NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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