Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04598412
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Dietary Protein Intake Patterns and Inadequate Protein Intake in Older Adults Among Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inadequate protein intake per day', 'timeFrame': 'One day', 'description': 'Percentage of older adults that did not eat enough protein per day according to the following cut points: 0.8, 1.0, and 1.2 g/kg/d'}, {'measure': 'Inadequate protein intake per meal', 'timeFrame': 'One day', 'description': 'Percentage of older adults that did not eat enough protein per meal according to the following cut points: 30 g/meal, or 0.4 g/kg/meal'}, {'measure': 'Meals per day with adequate protein content', 'timeFrame': 'One day', 'description': 'The number of meals per day that had enough protein (\\>30 g/meal, or \\>0.4 g/kg/meal).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein intake', 'Older adults'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The researchers will compare protein intake patterns per day and per meal among older adults from different countries. The analysis will also compare the proportion of inadequate protein intake per day (different cut points), per meal (breakfast, lunch, dinner), and the number of meals per day that reach an adequate protein content.', 'detailedDescription': "There will be a literature review in search of other studies reporting protein intake patterns in older adults. These studies must report total, and per-meal protein intake, evaluated through 24-h dietary recalls, food diaries or food frequency questionnaires. Afterwards, the researchers will contact the authors for data requests and analyze the data; these data will also include some demographic variables (e.g. sex, age, height, weight). Once the data are obtained, the patterns of protein intake will be compared among countries with an ANOVA test. As it is very likely that variances and/or sample sizes will be unequal, a Welch's correction and a Dunnett test for post hoc analyses will be performed. This analysis is going to be performed for the whole sample and by sex. Similarly, the proportion of older adults that do not reach the recommended amounts of protein in a daily (0.8, 1.0, 1.2 g/kg/day) and per meal basis (30 g, 0.4 g/kg) will be calculated. These proportions will be compared among countries with a chi-squared test and employing a z-test for proportions (with Bonferroni adjustment) to identify pairwise differences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community dwelling older adults (\\>60 y) from different countries.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community dwelling\n\nExclusion Criteria:\n\n* Incomplete data registries'}, 'identificationModule': {'nctId': 'NCT04598412', 'briefTitle': 'Comparison of Dietary Protein Intake Patterns and Inadequate Protein Intake in Older Adults Among Countries', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario de Ciencias de la Salud, Mexico'}, 'officialTitle': 'Comparison of Dietary Protein Intake Patterns and Inadequate Protein Intake in Older Adults Among Countries', 'orgStudyIdInfo': {'id': 'HGO-ICAAFyD18-6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mexican sample', 'description': 'Aged \\>60 years (n = 187)', 'interventionNames': ['Other: No intervention']}, {'label': 'German sample', 'description': 'Aged \\>75 years (n = 97)', 'interventionNames': ['Other: No intervention']}, {'label': 'Northamerican sample', 'description': 'Aged \\>60 years (n = 200)', 'interventionNames': ['Other: No intervention']}, {'label': 'British sample', 'description': 'Aged \\>70 years (n = 38)', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Cross-sectional', 'armGroupLabels': ['British sample', 'German sample', 'Mexican sample', 'Northamerican sample']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44430', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Alejandro Gaytán-González', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario de Ciencias de la Salud, Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital General de Occidente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Institute of Applied Sciences for Physical Activity and Sport', 'investigatorFullName': 'Juan Ricardo Lopez y Taylor', 'investigatorAffiliation': 'Centro Universitario de Ciencias de la Salud, Mexico'}}}}