Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-31 @ 10:54 AM
Study NCT ID:
NCT04738656
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2021-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Mediterranean Diet on Weight Loss After Endoscopic Bariatric Treatmen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-25', 'size': 211755, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-01-29T04:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly weight loss', 'timeFrame': 'Every week up to 24 weeks'}, {'measure': 'Weight relapse after 36 weeks', 'timeFrame': '1 time after 36 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic bariatric treatment', 'Excess weight loss', 'Excess body mass index', 'Mediterranean diet plan', 'Open protein diet plan'], 'conditions': ['Obesity', 'Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'All participants were weighed every week for 24 weeks, wearing light clothes to the nearest 0.1 kg, using a body composition analyzer. Height was determined during the first clinic evaluation using a fixed wall stadiometer to the nearest 0.1 cm, in standing position.\n\nIntervention: Participants followed a liquid diet plan during the first week after the endoscopic bariatric procedure (Bioenterics Intragastric Balloon - BIB - or Primary Obesity Surgery Endoluminal - POSE -). Subsequently, subjects were randomly assigned either a Mediterranean-style or a protein diet plan. Energy intake was calculated according to the Spanish Consensus on Bariatric Endoscopy.\n\nThe hypothesis of this project is to analyze whether the Mediterranean-style diet is more effective compared with the open protein diet plans in weight loss and weight relapse in subjects with obesity who underwent endoscopic bariatric therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic. Patients of Dorsia Clinics Surgery and Aesthetic Medicine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no previous gastric intervention\n* no hiatus hernias\n* not being pregnant or in breastfeeding\n* not having cardiac problems, and having regular values in coagulation and blood count,\n* having a positive psychological evaluation.\n\nExclusion Criteria:\n\n* lack of compliance with the dietary treatment\n* adverse effects of the surgery\n* refuse to complete the treatment\n* lack of adherence'}, 'identificationModule': {'nctId': 'NCT04738656', 'briefTitle': 'Effectiveness of the Mediterranean Diet on Weight Loss After Endoscopic Bariatric Treatmen', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Politècnica de Catalunya'}, 'officialTitle': 'Mediterranean-style and Open Protein Diet Plans on Weight Loss in Patients With Obesity After Endoscopic Bariatric Treatment', 'orgStudyIdInfo': {'id': 'UPCatalunya'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mediterranean-style diet plan', 'description': 'Mediterranean-style diet plan (6 months): 22% proteins, 53% carbohydrates, and 25% of lipids.\n\n52 participants.', 'interventionNames': ['Dietary Supplement: Diet plan']}, {'label': 'Open protein diet plan', 'description': 'Open protein presents (6 months) 40% of proteins, 29% carbohydrate and 31% of lipids.\n\n26 participants.', 'interventionNames': ['Dietary Supplement: Diet plan']}], 'interventions': [{'name': 'Diet plan', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mediterranean style is a non-restricted diet plan compared with the open protein diet plan', 'armGroupLabels': ['Mediterranean-style diet plan', 'Open protein diet plan']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'By email: antonio.egea@upc.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Politècnica de Catalunya', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Barcelona', 'class': 'OTHER'}, {'name': 'Clinica Dorsia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Antonio Sanchez Egea', 'investigatorAffiliation': 'Universitat Politècnica de Catalunya'}}}}