Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:02 AM
Study NCT ID:
NCT07431268
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Interventions to Reduce Postoperative Weight Loss and Improve Recovery After Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in weight in kilogram after orthognatic surgery', 'timeFrame': 'From enrollment, (14 days before surgery), to 8 weeks after surgery.', 'description': 'Weight changes was the primary measure of interest, assessed using the Tanita BC-418 Segmental Body Composition Analyzer.\n\nMeasurements were taken during scheduled hospital appointments; the pre-surgery examination, admission interview, and follow-up visits at week 1-, 3- and 8.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthognathic Surgery']}, 'descriptionModule': {'briefSummary': 'Objectives This randomized controlled trial aimed to assess whether structured dietary interventions, implemented both before and after orthognathic surgery, could minimize postoperative weight loss and thereby enhance recovery during the first eight weeks.\n\nMaterial and Methods The study was conducted at Aalborg University Hospital, Denmark, from April 2017 to April 2022, involving patients undergoing single- or bimaxillary surgery. Participants were randomly allocated into two intervention groups receiving nutritional supplements and one control group. Body composition was assessed using a Body Composition Analyzer at five time points: pre-surgery examination, admission, and follow-ups weeks 1, 3, and 8. Primary outcome was weight, secondary outcomes included BMI, fat mass, fat-free mass, total body water, and visceral fat rating. Additional data were collected on age, gender, type of surgery, and hospitalization duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of both sexes with dentofacial deformities who underwent single- or bimaxillary surgery (Le Fort I osteotomy and/or bilateral sagittal split osteotomy) were included in the study.\n\nExclusion Criteria: Patients not willing to complete the planned treatment in the intervention groups.'}, 'identificationModule': {'nctId': 'NCT07431268', 'briefTitle': 'Dietary Interventions to Reduce Postoperative Weight Loss and Improve Recovery After Orthognathic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Systematic Dietary Interventions to Minimize Postoperative Weight Loss and Enhance Recovery Following Orthognathic Surgery', 'orgStudyIdInfo': {'id': '2016-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controle', 'description': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'G-tube administered Nutrition and Protein drinks', 'description': 'Nutrition supplement: G-tube administered Nutrition and Protein drinks', 'interventionNames': ['Other: Intervention group receiving nutritional supplements through G-tube and Protein drinks']}, {'type': 'EXPERIMENTAL', 'label': 'Protein drink', 'description': 'Nutrition supplement: Protein drink', 'interventionNames': ['Other: Intervention group receiving nutritional supplements through Protein drinks']}], 'interventions': [{'name': 'Intervention group receiving nutritional supplements through G-tube and Protein drinks', 'type': 'OTHER', 'description': 'Nutrition supplement: G-tube administered Nutrition and Protein drinks', 'armGroupLabels': ['G-tube administered Nutrition and Protein drinks']}, {'name': 'Intervention group receiving nutritional supplements through Protein drinks', 'type': 'OTHER', 'description': 'Nutrition supplements recieved through intake of Protein drinks', 'armGroupLabels': ['Protein drink']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Karin Bundgaard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Marie Germund Nielsen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}