Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT01797757
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2013-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of MAG and Fish Oil Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C588285', 'term': '1-eicosapentaenoylglycerol'}, {'id': 'D000077403', 'term': 'Orlistat'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be accretion of EPA in erythrocytes at 21days', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': '• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons', 'timeFrame': 'from baseline to day 21'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EPA', 'LC-PUFA', 'Orlistat', 'Obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '27707818', 'type': 'DERIVED', 'citation': 'Cruz-Hernandez C, Destaillats F, Thakkar SK, Goulet L, Wynn E, Grathwohl D, Roessle C, de Giorgi S, Tappy L, Giuffrida F, Giusti V. Monoacylglycerol-enriched oil increases EPA/DHA delivery to circulatory system in humans with induced lipid malabsorption conditions. J Lipid Res. 2016 Dec;57(12):2208-2216. doi: 10.1194/jlr.P070144. Epub 2016 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'A potential application for unstructured monoacylglycerol (MAG) containing long chain polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed, it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other type of maldigestion/malabsorption. Potential applications of such concept are therefore related to disease conditions comprising low lipid digestion due to lipase activity insufficiency.\n\nIn the present study, in order to see the response information for eicosapentanoic acid (EPA) delivery, EPA will be provided either as a mixture of free monoacylglycerols or as triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under Orlistat® consumption will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65\n* Sex female\n* Body Mass Index (BMI) ≥ 30kg/m2 and \\< 40kg/m2\n* Subjects willing to undergo treatment with Orlistat® (Xenical).\n* Having obtained her written informed consent before any study related procedure including the pre-inclusion period.\n\nSubject exclusion criteria:\n\n* Binge eating disorder\n* Any other weight loss treatment(s) within the last 3 months\n* Vegetarians\n* History of metabolic, cardiovascular, hepatic or renal diseases\n* Obstructed bile duct\n* Diseases that could interfere with intestinal absorption History of abdominal / gastric surgery (except appendicectomy)\n* Use of drugs or illicit substances\n* Consumption of alcohol \\> 50 gr/week\n* Any other clinically significant abnormalities on screening laboratory evaluation (creatinine, Na, K, urique acide, ASAT, ALAT, Ph. Alc., yGT, Glycemia, total cholesterol, HDL, LDL, triglycerides) concentrations \\> 2.5 fold normal range\n* Pregnant or lactating mothers\n* Allergy to fish oil or other components (for e.g., gelatin or excepients of the capsule)\n* Use of any other supplements containing fish oil for the duration of the trial or 3 month before inclusion in trial.\n* Smokers\n* Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study\n* Bleeding disorders\n* Subject who cannot be expected to comply with the study procedures.\n* Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.'}, 'identificationModule': {'nctId': 'NCT01797757', 'briefTitle': 'Comparison of MAG and Fish Oil Efficacy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions', 'orgStudyIdInfo': {'id': '10.29.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil enriched with EPA + ORLISTAT', 'description': 'The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.\n\nThe Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.', 'interventionNames': ['Dietary Supplement: Fish oil enriched with EPA', 'Drug: Orlistat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAG-EPA', 'description': 'The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.', 'interventionNames': ['Dietary Supplement: MAG-EPA oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAG-EPA + ORLISTAT', 'description': 'The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.\n\nThe Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.', 'interventionNames': ['Dietary Supplement: MAG-EPA oil', 'Drug: Orlistat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil enriched with EPA', 'description': 'The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.', 'interventionNames': ['Dietary Supplement: Fish oil enriched with EPA']}], 'interventions': [{'name': 'Fish oil enriched with EPA', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fish oil enriched with EPA', 'Fish oil enriched with EPA + ORLISTAT']}, {'name': 'MAG-EPA oil', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['MAG-EPA', 'MAG-EPA + ORLISTAT']}, {'name': 'Orlistat', 'type': 'DRUG', 'armGroupLabels': ['Fish oil enriched with EPA + ORLISTAT', 'MAG-EPA + ORLISTAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'CHUV Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Vittorio Giusti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUV Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}