Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02130960
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resting Metabolic Rate Reliability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-05-05', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Metabolic Rate by Indirect Calorimetry', 'timeFrame': 'At least 3 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Respiratory Quotient Variation', 'timeFrame': 'At least 3 days', 'description': '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.'}, {'measure': 'Sense Wear Mini Armband verses Indirect Calorimetry', 'timeFrame': 'At least 3 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['RMR', 'Reliability', 'Obese', 'Energy Expenditure', 'Resting Energy Expenditure', 'Resting Metabolic Rate'], 'conditions': ['Resting Metabolic Rate Reliability']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will include up to 15 men and 15 women age 18 -65 years old with a BMI of 19 - 40 kg/m2.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 65 years old\n* BMI of 19 - 40 kg/m2\n* Women must not be pregnant or planning to become pregnant\n\nExclusion Criteria:\n\n* Age less than 18 or greater than 65\n* BMI less than 19 or greater than 40\n* Tobacco use\n* Taking medications that affect metabolic rate (unless weight stable for past 3 months)\n* Any disease that affects the metabolic rate'}, 'identificationModule': {'nctId': 'NCT02130960', 'briefTitle': 'Resting Metabolic Rate Reliability', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Resting Metabolic Rate Reliability', 'orgStudyIdInfo': {'id': 'GFHNRC027'}}, 'contactsLocationsModule': {'locations': [{'zip': '58203', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'James Roemmich, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}