Modulation of Metabolic Rate by Inorganic Nitrate
Dietary Inorganic Nitrate: Effects on Metabolic Rate, Reactive Oxygen Species Production, Glucose Uptake and Primary Myotube Respiration.
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedJanuary 3, 2014
January 1, 2014
5.5 years
December 16, 2013
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resting metabolic rate
Resting metabolic rate, measured after overnight fast using indirect calorimetry
day 4
Secondary Outcomes (3)
Thyroid hormone status
day 4
Glucose uptake
day 4
Nitrite infusion
30 minutes
Study Arms (4)
Sodium nitrate
ACTIVE COMPARATOR0.1 mmol NaNO3 / kg bodyweight / day for three days.
Sodium Chloride
PLACEBO COMPARATOR0.1 mmol NaCl / kg bodyweight / day for three days.
Sodium nitrite infusion
ACTIVE COMPARATORSodium nitrite (NaNO2) at a rate of 1, 10 and 100 nmol kg-1 min-1 (10 minutes per dose) was infused intravenously.
Saline infusion
PLACEBO COMPARATORSaline at a rate corresponding to 1, 10 and 100 nmol NaCl kg-1 min-1 (10 minutes per dose) was infused intravenously.
Interventions
Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp
Resting metabolic rate is measured by indirect calorimetry after an over-night fast
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
Eligibility Criteria
You may qualify if:
- Healthy volunteers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- The Swedish Research Councilcollaborator
- Swedish Heart Lung Foundationcollaborator
Study Sites (1)
Karolinska Institutet
Stockholm, 17177, Sweden
Related 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.
PMID: 21284982BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2013
First Posted
December 27, 2013
Study Start
March 1, 2008
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
January 3, 2014
Record last verified: 2014-01