Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 1:49 AM
Study NCT ID:
NCT00905892
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Fate Modifications of Saturated Fats After an Overfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D019446', 'term': 'Endotoxemia'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post prandial partitioning of exogenous lipids', 'timeFrame': 'Before and after overfeeding'}], 'secondaryOutcomes': [{'measure': 'Genes expression in adipose and muscle tissues', 'timeFrame': 'Before and after overfeeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['overfeeding', 'stable isotopes', 'lipoprotein metabolism', 'lipid oxidation', 'fat distribution', 'gene expression', 'endotoxemia', 'mass spectrometry/gas chromatography'], 'conditions': ['Obesity', 'Lipid Metabolism', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '30260393', 'type': 'DERIVED', 'citation': 'Segrestin B, Moreno-Navarrete JM, Seyssel K, Alligier M, Meugnier E, Nazare JA, Vidal H, Fernandez-Real JM, Laville M. Adipose Tissue Expansion by Overfeeding Healthy Men Alters Iron Gene Expression. J Clin Endocrinol Metab. 2019 Mar 1;104(3):688-696. doi: 10.1210/jc.2018-01169.'}, {'pmid': '24684464', 'type': 'DERIVED', 'citation': 'Seyssel K, Alligier M, Meugnier E, Chanseaume E, Loizon E, Canto C, Disse E, Lambert-Porcheron S, Brozek J, Blond E, Rieusset J, Morio B, Laville M, Vidal H. Regulation of energy metabolism and mitochondrial function in skeletal muscle during lipid overfeeding in healthy men. J Clin Endocrinol Metab. 2014 Jul;99(7):E1254-62. doi: 10.1210/jc.2013-4379. Epub 2014 Mar 31.'}, {'pmid': '22162470', 'type': 'DERIVED', 'citation': 'Alligier M, Meugnier E, Debard C, Lambert-Porcheron S, Chanseaume E, Sothier M, Loizon E, Hssain AA, Brozek J, Scoazec JY, Morio B, Vidal H, Laville M. Subcutaneous adipose tissue remodeling during the initial phase of weight gain induced by overfeeding in humans. J Clin Endocrinol Metab. 2012 Feb;97(2):E183-92. doi: 10.1210/jc.2011-2314. Epub 2011 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31\\_palmitic acid, d31\\_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).', 'detailedDescription': 'Healthy overweight and lean young men are subjected to an overfeeding during 56 days which corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et after : D56 overfeeding) they have ingested a breakfast with tracer (d31\\_palmitic acid, d31\\_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry (GC-OMS) in palmitic acid pool of lipid fractions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 55 years old\n* BMI 18 to 30 kg/m²\n* Stable physical activity\n* Safety subject during medical consultation\n\nExclusion Criteria:\n\n* Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)\n* Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)\n* Eating disorder\n* Intensive sportive activity\n* Subjects who Smoke\n* Claustrophobic subjects'}, 'identificationModule': {'nctId': 'NCT00905892', 'acronym': 'SURNUT', 'briefTitle': 'Metabolic Fate Modifications of Saturated Fats After an Overfeeding', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe'}, 'officialTitle': 'Metabolic Fate Modifications of Saturated Fats After an Overfeeding', 'orgStudyIdInfo': {'id': 'CRNHRA-09-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hyperlipidic overfeeding', 'type': 'DIETARY_SUPPLEMENT', 'description': '100g per day of cheese + 40g per day of almonds + 20g per day of butter'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre de recherche en nutrition humaine Rhone-Alpes', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Martine Laville, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Recherche en Nutrition Humaine Rhone-Alpe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Martine Laville PhD, MD', 'oldOrganization': 'CRNHRA'}}}}