Modulation of Metabolic Rate by Inorganic Nitrate

Resting Metabolic Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022176
• Other study ID #: JETF-6996-NO
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: January 2, 2014
• Start date: March 2008
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Resting Metabolic Rate

Intervention

Other:
• Glucose Uptake
Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp
• Resting metabolic rate
Resting metabolic rate is measured by indirect calorimetry after an over-night fast
• 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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Heart Lung Foundation, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Larsen FJ, Schiffer TA, Borniquel S, Sahlin K, Ekblom B, Lundberg JO, Weitzberg E. Dietary inorganic nitrate improves mitochondrial efficiency in humans. Cell Metab. 2011 Feb 2;13(2):149-59. doi: 10.1016/j.cmet.2011.01.004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting metabolic rate	Resting metabolic rate, measured after overnight fast using indirect calorimetry	day 4	No
Secondary	Thyroid hormone status		day 4	No
Secondary	Glucose uptake	Glucose uptake measured with oral glucose tolerance test and euglycemic clamp	day 4	No
Secondary	Nitrite infusion	Effect on resting metabolic rate when infusing escalating intravenous doses of sodium nitrite or saline solution	30 minutes	No