Modulation of Metabolic Rate by Inorganic Nitrate

NCT ID: NCT02022176

Last Updated: 2014-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Resting Metabolic Rate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sodium nitrate

0.1 mmol NaNO3 / kg bodyweight / day for three days.

Group Type ACTIVE_COMPARATOR

Glucose Uptake

Intervention Type OTHER

Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp

Resting metabolic rate

Intervention Type OTHER

Resting metabolic rate is measured by indirect calorimetry after an over-night fast

Sodium Chloride

0.1 mmol NaCl / kg bodyweight / day for three days.

Group Type PLACEBO_COMPARATOR

Glucose Uptake

Intervention Type OTHER

Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp

Resting metabolic rate

Intervention Type OTHER

Resting metabolic rate is measured by indirect calorimetry after an over-night fast

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.

Group Type ACTIVE_COMPARATOR

Nitrite infusion

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Nitrite infusion

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucose Uptake

Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp

Intervention Type OTHER

Resting metabolic rate

Resting metabolic rate is measured by indirect calorimetry after an over-night fast

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Healthy volunteers
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eddie Weitzberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21284982 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JETF-6996-NO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methemoglobin Concentration in High Dose Inhaled Nitric Oxide
NCT05612074 ACTIVE_NOT_RECRUITING EARLY_PHASE1