Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-28 @ 7:25 AM
Study NCT ID:
NCT06494566
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2019-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Supplementation After Surgical Treatment of Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D055948', 'term': 'Sarcopenia'}], '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'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D008899', 'term': 'Mineral Oil'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D010577', 'term': 'Petrolatum'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be randomized in blocks of two participants, at a 1:1 ratio, for the two groups of treatment. For every two participants, there will be one block. The number of each block will be hold in a nontransparent, seriated, sealed envelope. Intervention capsules will be opaque and stored in identical containers by a single investigator, who will not take part in data collection or analysis.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.', 'description': 'Measurement with digital scale, patient standing, barefoot. kilograms (kg)'}, {'measure': 'Height', 'timeFrame': 'Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.', 'description': 'Height measurement, patient standing, barefoot. Unit of measurement: meters (m).'}], 'secondaryOutcomes': [{'measure': 'Manual Grip Strength', 'timeFrame': 'Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.', 'description': 'Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf).'}, {'measure': '6-Minute Walk Test', 'timeFrame': 'Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.', 'description': 'Walking with measurements of distance covered. Units of measurement: meters.'}, {'measure': 'Electrical Bioimpedance - Percentage of muscle mass', 'timeFrame': 'Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.', 'description': 'Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).'}, {'measure': 'Electrical Bioimpedance - Body fat percentage', 'timeFrame': 'Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.', 'description': 'Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Lipid profile', 'Bariatric surgery', 'Metabolic surgery'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.', 'detailedDescription': 'Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30kg/m2\n* Candidate to bariatric and metabolic surgery\n\nExclusion Criteria:\n\n* Use of Omega-3\n* Contraindication to bioimpedance analysis\n* Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT06494566', 'briefTitle': 'Omega-3 Supplementation After Surgical Treatment of Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '10311419.5.0000.5333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3', 'description': 'Omega-3 2000mg (940mg of EPA and 660mg of DHA) in gastro resistant capsule by mouth once a day for 90 days, starting on day sixteen after surgery.', 'interventionNames': ['Dietary Supplement: Omega-3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery.', 'interventionNames': ['Dietary Supplement: Mineral Oil']}], 'interventions': [{'name': 'Omega-3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Omega-3 capsule', 'armGroupLabels': ['Omega-3']}, {'name': 'Mineral Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mineral Oil Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-072', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Irmandade Santa Casa de Misericórdia de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90040-371', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}