Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT05897892
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days. Balanced nutrition education undertaken to all subjects at two groups once at the first week of study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mangrove sword bean food bar on the weight of older people', 'timeFrame': 'Two weeks', 'description': '50 g mangrove sword bean food bar each day given to treatment group. 50 g sword bean food bar each day consumed by the control group. Weight measured by digital weighing SECA by trained enumerator at the first week and the second week of study.'}], 'secondaryOutcomes': [{'measure': 'Balanced nutrition knowledge of older people', 'timeFrame': 'Two weeks', 'description': 'Both groups received the balance nutrition education once at the second week of study.\n\nThe knowledge change of older people measured by the baseline and end-line questionnaires by trained enumerators'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older people', 'disaster', 'weight', 'mangrove-sword bean food bar'], 'conditions': ['Nutrition Disorders in Old Age', 'Disaster']}, 'referencesModule': {'references': [{'pmid': '38650640', 'type': 'DERIVED', 'citation': 'Fatmah F. Effectiveness of mangrove sword bean food bar addressed to older people of landslide disaster victims. Front Nutr. 2024 Apr 8;11:1291580. doi: 10.3389/fnut.2024.1291580. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical study is to assess the api-api mangrove sword bean food bar effect on the older people's weight affected by a landslide\n\nThe main questions aimed to answer are:\n\n* Can api-api mangrove sword bean food bar improve the weight of older people affected by landslide?\n* Can balanced nutrition education increase the older peoples' knowledge?\n\nParticipants divided in the two groups i.e.:\n\n* Treatment group received 50 g mangrove sword bean food bar each day during 15 days.\n* Control group received 50 g sword bean food bar each day during 15 days.\n* Both groups obtained balanced nutrition of older people education once at the first week of study.", 'detailedDescription': 'Treatment group received 50 g mangrove sword bean food bar each day during 15 days.\n\nControl group received 50 g sword bean food bar each day during 15 days. Both groups obtained balanced nutrition of older people education once at the first week of study.\n\nCompliance monitoring to control the food compliance by the subjects at two groups through home visit, weight measurement, three days food recall, and food bar distribution checking by trained enumerators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 years old or above\n* Male and female\n* Living in Cihanjuang Village, Sumedang District, West Java Province Indonesia who affected by the landslide disaster\n* Had normal, under-, or over-nutrition status\n* Not suffering from chronic diseases or degenerative diseases during the study.\n* Willing to avoid consumption of any snacks other than the food bars and plain water.\n\nExclusion Criteria:\n\n* Having difficulty mobilities to run daily basic activities.\n* Suffered from infectious and or a chronical diseases.'}, 'identificationModule': {'nctId': 'NCT05897892', 'acronym': 'FF', 'briefTitle': 'The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'School of Environmental Sciences - University of Indonesia', 'orgStudyIdInfo': {'id': 'SILUI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Treatment group received 50 g mangrove sword bean food bar each day during 15 days.', 'interventionNames': ['Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Control group received 50 g sword bean food bar per day during 15 days.', 'interventionNames': ['Dietary Supplement: Clinical study on the mangrove sword bean food bar effect for older people']}], 'interventions': [{'name': 'Clinical study on the mangrove sword bean food bar effect for older people', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['EFP'], 'description': 'The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.', 'armGroupLabels': ['Control Group', 'Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sumedang', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Health integrated post for older people office', 'geoPoint': {'lat': -6.85861, 'lon': 107.91639}}], 'overallOfficials': [{'name': 'Fatmah Fatmah, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatmah Fatmah', 'investigatorAffiliation': 'Indonesia University'}}}}