Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT03566758
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2018-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Mass and Nutritional Risk in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-06-21', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COAST (Comprehensive Older Adult Screening Tool) score', 'timeFrame': 'baseline only', 'description': 'Ability of the COAST score to predict depleted muscle mass. A five question survey, scored from 0 to 8 points; 8 being the maximum score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the COAST (comprehensive older adult screening tool) to muscle mass as determined by BIA (bioelectric impedance analysis) and thus, determine if the COAST is a valid predictor of muscle loss in older adults. This study follows a comparison of COAST to MNA and will further test the validity of the COAST nutrition screening tool.', 'detailedDescription': 'The association between muscle mass, as determined by BIA (bioelectric impedance analysis), and the recently developed COAST (Comprehensive Older Adult Screening Tool) has not been studied. Therefore, the main objective of this study is to test the correlations between muscle mass, measured by BIA, and COAST. The population to be studied will be older adults (n=150). Participants will be included if they are 60 years or older, willing to have weight, height, handgrip and body composition measured, willing to provided demographic information and answer questions related to their nutritional and health status. Individuals will be excluded if they have had recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device. Participants will be recruited from community groups in Florida. Participants muscle mass will be measured using BIA. Also, their handgrip strength will be tested using a dynamometer. Weight and height will be measured and demographic information will be collected. In addition, the participants will be given COAST (5 questions related to their nutritional and health status). The associations among BIA, handgrip strength and the COAST will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older adults', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 -100 years of age\n* willing to weight, height, handgrip and body composition measured, willing to provide demographic information and answer questions related to their nutritional and health status\n\nExclusion Criteria:\n\n* recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device.'}, 'identificationModule': {'nctId': 'NCT03566758', 'briefTitle': 'Muscle Mass and Nutritional Risk in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Association Between Muscle Mass and Nutritional Risk by COAST in Older Adults', 'orgStudyIdInfo': {'id': 'IRB201801247'}}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Food Science and Human Nutrition Department', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Wendy J Dahl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}