Resting Metabolic RateNCT02022176
Modulation of Metabolic Rate by Inorganic Nitrate
A study testing Glucose Uptake, Resting metabolic rate and Nitrite infusion in people with Resting Metabolic Rate, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Resting Metabolic Rate
- What is being tested?
- Glucose Uptake, Resting metabolic rate and Nitrite infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Resting Metabolic Rate
- Being tested
- Glucose Uptake, Resting metabolic rate, Nitrite infusion
- Keywords
- Nitrate, Nitrite, Nitric oxide, Resting metabolic rate, Glucose uptake, Insulin sensitivity, Reactive oxygen species production, inorganic nitrate, Sodium nitrite infusion
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose UptakeOther
Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp
Resting metabolic rateOther
Resting metabolic rate is measured by indirect calorimetry after an over-night fast
Nitrite infusionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Sodium nitrate | Active comparator | 0.1 mmol NaNO3 / kg bodyweight / day for three days. Receives: Other: Glucose Uptake; Other: Resting metabolic rate |
| Sodium Chloride | Placebo comparator | 0.1 mmol NaCl / kg bodyweight / day for three days. Receives: Other: Glucose Uptake; Other: Resting metabolic rate |
| Sodium nitrite infusion | Active comparator | Sodium nitrite (NaNO2) at a rate of 1, 10 and 100 nmol kg-1 min-1 (10 minutes per dose) was infused intravenously. Receives: Other: Nitrite infusion |
| Saline infusion | Placebo comparator | Saline at a rate corresponding to 1, 10 and 100 nmol NaCl kg-1 min-1 (10 minutes per dose) was infused intravenously. Receives: Other: Nitrite infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting metabolic rate
Resting metabolic rate, measured after overnight fast using indirect calorimetry
Measured: day 4
Secondary outcomes (3)
Thyroid hormone status
Measured: day 4
Glucose uptake
Glucose uptake measured with oral glucose tolerance test and euglycemic clamp
Measured: day 4
Nitrite infusion
Effect on resting metabolic rate when infusing escalating intravenous doses of sodium nitrite or saline solution
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMar 2008
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Metabolic RateStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Eddie Weitzberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022176
- Sponsor's protocol ID
- JETF-6996-NO
- Status last verified
- Jan 2014
- First submitted
- 16 Dec 2013
- Last updated
- 3 Jan 2014
- Results posted
- No
Publications
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.
PubMed 21284982
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Inorganic Nitrate: Effects on Metabolic Rate, Reactive Oxygen Species Production, Glucose Uptake and Primary Myotube Respiration.
- ClinicalTrials.gov ID
- NCT02022176
- Acronym / sponsor ID
- JETF-6996-NO
- Conditions
- Resting Metabolic Rate
- Keywords
- Nitrate, Nitrite, Nitric oxide, Resting metabolic rate, Glucose uptake, Insulin sensitivity, Reactive oxygen species production, inorganic nitrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Heart Lung Foundation
- Study start
- Mar 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium nitrate | Active comparator | Other: Glucose Uptake, Other: Resting metabolic rate0.1 mmol NaNO3 / kg bodyweight / day for three days. |
| Sodium Chloride | Placebo comparator | Other: Glucose Uptake, Other: Resting metabolic rate0.1 mmol NaCl / kg bodyweight / day for three days. |
| Sodium nitrite infusion | Active comparator | Other: Nitrite infusionSodium 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 comparator | Other: Nitrite infusionSaline at a rate corresponding to 1, 10 and 100 nmol NaCl kg-1 min-1 (10 minutes per dose) was infused intravenously. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose UptakeGlucose uptake is measured by oral glucose tolerance test and euglycemic clamp | Other | Sodium Chloride, Sodium nitrate |
| Resting metabolic rateResting metabolic rate is measured by indirect calorimetry after an over-night fast | Other | Sodium Chloride, Sodium nitrate |
| Nitrite infusionSodium 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 | Other | Saline infusion, Sodium nitrite infusion |
Primary outcome
Resting metabolic rate
Time frame: day 4
Resting metabolic rate, measured after overnight fast using indirect calorimetry
3 secondary outcomes
Thyroid hormone status
Time frame: day 4
Glucose uptake
Time frame: day 4
Nitrite infusion
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
- Background: PubMed 21284982Larsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose Uptake, Resting metabolic rate and Nitrite infusion in people with Resting Metabolic Rate, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting metabolic rate (time frame: day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.