Resting Metabolic Rate ReliabilityNCT02130960
Resting Metabolic Rate Reliability
An observational study of Resting Metabolic Rate Reliability, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
This research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resting Metabolic Rate Reliability
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include up to 15 men and 15 women age 18 -65 years old with a BMI of 19 - 40 kg/m2.
Who may be able to join
- Age 18 - 65 years old
- BMI of 19 - 40 kg/m2
- Women must not be pregnant or planning to become pregnant
Who cannot join
- Age less than 18 or greater than 65
- BMI less than 19 or greater than 40
- Tobacco use
- Taking medications that affect metabolic rate (unless weight stable for past 3 months)
- Any disease that affects the metabolic rate
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
This research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest.
- Conditions
- Resting Metabolic Rate Reliability
- Keywords
- RMR, Reliability, Obese, Energy Expenditure, Resting Energy Expenditure, Resting Metabolic Rate
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate by Indirect Calorimetry
The within-subject coefficient of variation for resting metabolic rate (RMR) will be less than 10%. Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing.
Measured: At least 3 days
Secondary outcomes (2)
Respiratory Quotient Variation
The within-subject coefficient of variation for respiratory quotient (RQ) will be less than 10%. Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing.
Measured: At least 3 days
Sense Wear Mini Armband verses Indirect Calorimetry
The limits of agreement of Sense Wear Mini Armband (SWA)-estimated resting energy expenditure (REE) with indirect calorimetry measures of REE will be large (+ 500 kcal). Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing.
Measured: At least 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resting Metabolic Rate ReliabilityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130960
- Sponsor's protocol ID
- GFHNRC027
- Status last verified
- Jan 2022
- First submitted
- 30 Apr 2014
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Metabolic Rate Reliability
- ClinicalTrials.gov ID
- NCT02130960
- Acronym / sponsor ID
- GFHNRC027
- Conditions
- Resting Metabolic Rate Reliability
- Keywords
- RMR, Reliability, Obese, Energy Expenditure, Resting Energy Expenditure, Resting Metabolic Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 May 2014 (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.
This research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include up to 15 men and 15 women age 18 -65 years old with a BMI of 19 - 40 kg/m2.
Key inclusion criteria (3 listed)
- Age 18 - 65 years old
- BMI of 19 - 40 kg/m2
- Women must not be pregnant or planning to become pregnant
Key exclusion criteria (5 listed)
- Age less than 18 or greater than 65
- BMI less than 19 or greater than 40
- Tobacco use
- Taking medications that affect metabolic rate (unless weight stable for past 3 months)
- Any disease that affects the metabolic rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting Metabolic Rate by Indirect Calorimetry
Time frame: At least 3 days
The within-subject coefficient of variation for resting metabolic rate (RMR) will be less than 10%. Testing will occur on non-consecutive days, with a compliance and menstrual cycle questionnaire prior to testing.
2 secondary outcomes
Respiratory Quotient Variation
Time frame: At least 3 days
Sense Wear Mini Armband verses Indirect Calorimetry
Time frame: At least 3 days
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 2 Feb 2022.
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.
James Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resting Metabolic Rate Reliability, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
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 3 inclusion and 5 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 2 Feb 2022. 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 United States. 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. 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 by Indirect Calorimetry (time frame: At least 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2022.