- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02130960
Resting Metabolic Rate Reliability
January 18, 2022 updated by: USDA Grand Forks Human Nutrition Research Center
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Dakota
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Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Age 18 - 65 years old
- BMI of 19 - 40 kg/m2
- Women must not be pregnant or planning to become pregnant
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting Metabolic Rate by Indirect Calorimetry
Time Frame: At least 3 days
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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.
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At least 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Quotient Variation
Time Frame: At least 3 days
|
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.
|
At least 3 days
|
Sense Wear Mini Armband verses Indirect Calorimetry
Time Frame: At least 3 days
|
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.
|
At least 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 30, 2014
First Submitted That Met QC Criteria
May 5, 2014
First Posted (Estimate)
May 6, 2014
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
January 18, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- GFHNRC027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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