Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT00827450
Status:
COMPLETED
Last Update Posted:
2012-02-24
First Post:
2009-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-23', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intra-hepatocellular lipid (IHCL) concentration', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}], 'secondaryOutcomes': [{'measure': 'fasting plasma triglycerides', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}, {'measure': 'fasting net lipid oxidation', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}, {'measure': 'fasting net carbohydrate oxidation', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}, {'measure': 'whole body ketone bodies turnover and oxidation (13C 3-hydroxybutyrate)', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}, {'measure': 'whole body glucose turnover (6,6 2H2 glucose)', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}, {'measure': 'whole body glycerol turnover (2H5 glycerol)', 'timeFrame': 'will be measured after 6 days on a hypercaloric, high fructose (4g/kg body weight/day) diet +/- treatement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatic steatosis', 'coffee', 'fructose', 'lipids'], 'conditions': ['Hepatic Steatosis']}, 'referencesModule': {'references': [{'pmid': '24257718', 'type': 'DERIVED', 'citation': 'Lecoultre V, Carrel G, Egli L, Binnert C, Boss A, MacMillan EL, Kreis R, Boesch C, Darimont C, Tappy L. Coffee consumption attenuates short-term fructose-induced liver insulin resistance in healthy men. Am J Clin Nutr. 2014 Feb;99(2):268-75. doi: 10.3945/ajcn.113.069526. Epub 2013 Nov 20.'}]}, 'descriptionModule': {'briefSummary': "This study will assess\n\n* whether coffee consumption protects against fructose-induced hepatic steatosis in healthy humans\n* whether the protective effect of coffee is dependent on it's antioxidant composition", 'detailedDescription': 'Epidemiological studies suggest that coffee consumption improves glucose homeostasis in insulin resistant subjects. An increase in intrahepatic lipids (hepatic steatosis) is highly prevalent in patients with the metabolic syndrome and may be used as a marker of altered hepatic lipid metabolism. Such an increased hepatic lipids content can be experimentally produced in healthy humans by a 6-day high fructose diet.\n\nThe purpose of this study is to evaluate whether coffee prevents hepatic lipid deposition in healthy male subjects fed a fructose-rich hypercaloric diet. Both caffeine and antioxidants (yet unspecified) may be involved.. To sort out the role of caffeine and antioxidants, we will test 3 different soluble coffee, ie fully torrefied decaffeinated coffee , partially torrefied decaffeinated coffee, and partially torrefied caffeinated coffee.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 19 and 15 kg/m2\n* less than 30 min physical activity /day\n* habitual coffee consumption less than three cupy /day\n* consumption of caffeine-containing sodas less than 2 servings/day\n* non-smoker\n\nExclusion Criteria:\n\n* consumption of alcohol more than 40g/day\n* presence of metallic foreign bodies\n* history of eye surgery\n* family history of diabetes mellitus\n* history of food intolerance\n* vegetarians'}, 'identificationModule': {'nctId': 'NCT00827450', 'acronym': 'COLIBRI', 'briefTitle': 'Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne'}, 'officialTitle': 'Effects of Coffees With Various Compositions of Antioxidants on Hepatic Steatosis Induced by a High Fructose, Hypercaloric Diet', 'orgStudyIdInfo': {'id': 'COLIBRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Ctl', 'description': 'control isocaloric diet; no coffee', 'interventionNames': ['Dietary Supplement: Ctl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HF', 'description': 'Hypercaloric. high fructose diet; no coffee', 'interventionNames': ['Dietary Supplement: High fructose diet; no coffee']}, {'type': 'EXPERIMENTAL', 'label': 'C1', 'description': 'Hypercaloric, high fructose diet; caffeine-free, torrefied coffee', 'interventionNames': ['Dietary Supplement: fully torrefied, caffeine-free coffee']}, {'type': 'EXPERIMENTAL', 'label': 'C2', 'description': 'Hypercaloric, high fructose diet; caffeine-free, partially torrefied coffee', 'interventionNames': ['Dietary Supplement: partially torrefied, caffeine-free coffee']}, {'type': 'EXPERIMENTAL', 'label': 'C3', 'description': 'Hypercaloric, high fructose diet; caffeinated, partially torrefied coffee', 'interventionNames': ['Dietary Supplement: Partially torrefied, caffeinated coffee']}], 'interventions': [{'name': 'Ctl', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Control, isocaloric diet; no coffee', 'armGroupLabels': ['Ctl']}, {'name': 'High fructose diet; no coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hypercaloric, high fructose diet; no coffee', 'armGroupLabels': ['HF']}, {'name': 'fully torrefied, caffeine-free coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hypercaloric, high fructose diet + coffee', 'armGroupLabels': ['C1']}, {'name': 'partially torrefied, caffeine-free coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hypercaloric, high fructose diet + coffee', 'armGroupLabels': ['C2']}, {'name': 'Partially torrefied, caffeinated coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Hypercaloric, high fructose diet + coffee', 'armGroupLabels': ['C3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre d\'investigations cliniques "cardiomet"/ CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Luc Tappy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physiology, University of Lausanne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nestlé Research Center, Vers-chez-les-blanc, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of physiology', 'investigatorFullName': 'Luc Tappy, MD', 'investigatorAffiliation': 'University of Lausanne'}}}}