Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 12:59 PM
Study NCT ID:
NCT01446068
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2011-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Postprandial Inflammation in Lean and Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-10-03', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-6 (serum)', 'timeFrame': '4h vs 0h', 'description': 'A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h'}], 'secondaryOutcomes': [{'measure': 'Glucose (serum)', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'Triglyceride (serum)', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'Insulin (serum)', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'high sensitivity C-Reactive Protein', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'HDL-cholesterol', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'Total cholesterol', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'Total cholesterol / HDL cholesterol', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'Interleukin-6 (serum)', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}, {'measure': 'Glucagon-like-protein-1 (serum)', 'timeFrame': '0h, 1h 2h, 4h, 6h'}, {'measure': 'Endotoxin (serum)', 'timeFrame': '0h, 1h, 2h, 4h, 6h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nutritional Intervention', 'Nutritional and Metabolic Diseases', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '24812072', 'type': 'DERIVED', 'citation': 'Schwander F, Kopf-Bolanz KA, Buri C, Portmann R, Egger L, Chollet M, McTernan PG, Piya MK, Gijs MA, Vionnet N, Pralong F, Laederach K, Vergeres G. A dose-response strategy reveals differences between normal-weight and obese men in their metabolic and inflammatory responses to a high-fat meal. J Nutr. 2014 Oct;144(10):1517-23. doi: 10.3945/jn.114.193565. Epub 2014 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for lean subjects:\n\n* age 25-50\n* 20\\<BMI\\<25\n* waist circumference \\<94cm\n\nInclusion Criteria for obese subjects\n\n* age-matched to healthy subjects\n* 30\\<BMI\\<40\n* waist circumference \\>102cm\n\nExclusion Criteria for lean and obese subjects:\n\n* Physiological or psychological diseases\n* Allergies to food or intolerance to high-fat meal\n* Vegetarians\n* Chronic intake of drugs\n* Smokers\n* Diabetes mellitus Type I and II\n* Debilitating kidney diseases\n* Debilitating liver diseases\n* Clinically established coronary heart diseases\n* Ingestion of vitamins or dietary supplements during the course of the study'}, 'identificationModule': {'nctId': 'NCT01446068', 'briefTitle': 'Comparison of Postprandial Inflammation in Lean and Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Agroscope Liebefeld-Posieux Research Station ALP'}, 'orgStudyIdInfo': {'id': 'NUTRICHIP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lean Subjects', 'interventionNames': ['Dietary Supplement: High-fat meal']}, {'type': 'EXPERIMENTAL', 'label': 'Obese subjects', 'interventionNames': ['Dietary Supplement: High-fat meal']}], 'interventions': [{'name': 'High-fat meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Three caloric doses of high-fat meal (500, 1000, 1500 kcal)', 'armGroupLabels': ['Lean Subjects', 'Obese subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3003', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Agroscope Liebefeld-Posieux ALP Research Station', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'University Hospital Inselspital, Berne', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Kurt Laederach, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inselspital University of Berne'}, {'name': 'Katrin Bolanz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Agroscope Liebefeld-Posieux ALP Research Station'}, {'name': 'Flurina Schwander, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Agroscope Liebefeld-Posieux ALP Research Station'}, {'name': 'Caroline Buri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselspital University of Berne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agroscope Liebefeld-Posieux Research Station ALP', 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}