Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02705560
Status:
UNKNOWN
Last Update Posted:
2016-03-10
First Post:
2016-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Dietary Biomarkers and Metabolic Effects After the Intake of Milk and Cheese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018955', 'term': 'CD36 Antigens'}, {'id': 'D006244', 'term': 'Hardness'}], 'ancestors': [{'id': 'D010980', 'term': 'Platelet Membrane Glycoproteins'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D050612', 'term': 'Fatty Acid Transport Proteins'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D051122', 'term': 'Scavenger Receptors, Class B'}, {'id': 'D051116', 'term': 'Receptors, Scavenger'}, {'id': 'D011973', 'term': 'Receptors, LDL'}, {'id': 'D018110', 'term': 'Receptors, Lipoprotein'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-05', 'studyFirstSubmitDate': '2016-03-05', 'studyFirstSubmitQcDate': '2016-03-05', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of dietary biomarkers of cheese and milk intake', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Transcriptomics analyses / gene expression', 'timeFrame': '6 hours'}, {'measure': 'Blood cell count and cell type determination', 'timeFrame': '6 hours'}, {'measure': 'Glucose', 'timeFrame': '24 hours'}, {'measure': 'Insulin', 'timeFrame': '24 hours'}, {'measure': 'Triacylglycerides', 'timeFrame': '24 hours'}, {'measure': 'Total cholesterol', 'timeFrame': '24 hours'}, {'measure': 'HDL cholesterol', 'timeFrame': '24 hours'}, {'measure': 'LDL cholesterol', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32133503', 'type': 'DERIVED', 'citation': 'Pimentel G, Burnand D, Munger LH, Pralong FP, Vionnet N, Portmann R, Vergeres G. Identification of Milk and Cheese Intake Biomarkers in Healthy Adults Reveals High Interindividual Variability of Lewis System-Related Oligosaccharides. J Nutr. 2020 May 1;150(5):1058-1067. doi: 10.1093/jn/nxaa029.'}, {'pmid': '28753012', 'type': 'DERIVED', 'citation': 'Munger LH, Trimigno A, Picone G, Freiburghaus C, Pimentel G, Burton KJ, Pralong FP, Vionnet N, Capozzi F, Badertscher R, Vergeres G. Identification of Urinary Food Intake Biomarkers for Milk, Cheese, and Soy-Based Drink by Untargeted GC-MS and NMR in Healthy Humans. J Proteome Res. 2017 Sep 1;16(9):3321-3335. doi: 10.1021/acs.jproteome.7b00319. Epub 2017 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'Dietary biomarkers are compounds in biofluids that directly reflect the intake of specific foods or food groups. Their exploration and use in the field of dietary assessments could provide an objective measure of actual intake complementing classical assessment methods (e.g. food frequency questionnaire, 24h recalls). To date, only a limited number of foods have been covered by validated biomarkers.\n\nThe study is part of the international project "The Food Biomarker Alliance (FOODBALL)". The study described here has been assigned to assess biomarkers of the intake of milk and cheese. Up to now, there is an evident lack of data on specific and validated biomarkers of milk and cheese (dairy products), which belong to the most relevant public health related foods in Europe. This study will further provide novel insights into the influence of fermentation of milk-based foods on metabolic effects and postprandial adaptations, which has not yet been studied in depth before using cheese as fermented product. Outcomes will support and expand earlier findings on correlation between the intake of fermented dairy products intake and human health.', 'detailedDescription': 'This is an acute, randomized, controlled, cross-over study designed to identify dietary biomarkers of milk and cheese intake and to asses metabolic effects after the ingestion of a non-fermented product (milk) and a fermented product (cheese) in healthy subjects.\n\nTwelve healthy participants (six women, six men) in fasted state will consume three different foods in a randomized order on three different study days. Two days prior to each dietary intervention, the run-in period is initiated, during which participants have to follow a restricted diet. Participants will receive a standardised meal for the last dinner during run-in phase. The same meal will be served on the day of the dietary intervention for lunch and for dinner (period of controlled diet). Before and after ingestion of the test foods, blood samples and urine samples will be collected (up to 6 hours). Additionally, 24h-samples will be collected. Primary outcomes (metabolites) will be measured in blood serum and plasma collected at 6 different time points and in urine collected at 7 different time points. Transcriptomics analysis will be performed on whole blood samples collected at 4 time points while clinical chemistry parameters will be assessed in blood samples withdrawn at 6 different time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females\n* Aged 18 - 40 years\n* BMI \\> 18.5 and \\< 30 kg/m2\n* Daily consumption of milk\n* No adverse effects after intake of 600 ml of milk\n\nExclusion Criteria:\n\n* Smokers\n* Diagnosed health condition (chronic or infectious disease)\n* Taking medication (oral contraceptive pill is allowed)\n* Taking nutritional supplements (e.g. vitamins, minerals)\n* Pregnant, lactating\n* Antibiotics treatment 6 months prior to intervention\n* Allergy to milk\n* Allergy to soy\n* Known intolerance to lactose\n* Other food allergies or intolerances (e.g. histamine)\n* Anemia (hemoglobin \\< 120 g/l) at the screening visit\n* Iron deficiency (ferritin \\< 30 µg/l) at the screening visit\n* Not willing/able to consume all test foods (milk, cheese and soy drink)\n* Not willing/able to consume standardized meals\n* Not willing to avoid drinking alcohol during study days\n* Not willing to follow nutritional restrictions during study days'}, 'identificationModule': {'nctId': 'NCT02705560', 'briefTitle': 'Assessment of Dietary Biomarkers and Metabolic Effects After the Intake of Milk and Cheese', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Randomized, Controlled, Cross-Over Study to Assess Dietary Biomarkers and Metabolic Effects After a Single Dose of Milk and Cheese in Healthy Subjects', 'orgStudyIdInfo': {'id': '347/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cow´s milk (3.9% fat, pasteurized)', 'description': 'Cow´s milk (3.9% fat, pasteurized) Single dose, 600 ml milk', 'interventionNames': ['Other: Cow´s milk (3.9% fat, pasteurized)']}, {'type': 'EXPERIMENTAL', 'label': 'Hard, yellow cheese', 'description': 'Hard, yellow cheese Single dose, 100 g cheese\n\n\\+ 500 ml water', 'interventionNames': ['Other: hard, yellow cheese']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soy based drink', 'description': 'Soy based drink Single dose, 600 ml soy drink (soy drink + plant based cream)', 'interventionNames': ['Other: Soy based drink']}], 'interventions': [{'name': 'Cow´s milk (3.9% fat, pasteurized)', 'type': 'OTHER', 'description': '600 ml full fat milk (organic, pasteurized, 400 kcal)', 'armGroupLabels': ['Cow´s milk (3.9% fat, pasteurized)']}, {'name': 'hard, yellow cheese', 'type': 'OTHER', 'description': '100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal)', 'armGroupLabels': ['Hard, yellow cheese']}, {'name': 'Soy based drink', 'type': 'OTHER', 'description': '600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)', 'armGroupLabels': ['Soy based drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'François Pralong, MD', 'role': 'CONTACT', 'email': 'francois.pralong@chuv.ch', 'phone': '004121 314 05 96'}], 'facility': 'Service of Endocrinology, Diabetes and Metabolism, University Hospital, CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'François Pralong, MD', 'role': 'CONTACT', 'email': 'francois.pralong@chuv.ch', 'phone': '004121 314 05 96'}, {'name': 'Linda Münger, PHD', 'role': 'CONTACT', 'email': 'linda.muenger@agroscope.admin.ch', 'phone': '004158 463 83 77'}], 'overallOfficials': [{'name': 'François Pralong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agroscope Liebefeld-Posieux Research Station ALP', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof, MD', 'investigatorFullName': 'Francois Pralong', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}