Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02836106
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'D002079', 'term': 'Butter'}, {'id': 'D002611', 'term': 'Cheese'}], 'ancestors': [{'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D043302', 'term': 'Cultured Milk Products'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000074421', 'term': 'Fermented Foods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in levels of circulating triglycerides', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}], 'secondaryOutcomes': [{'measure': 'Changes in total cholesterol and lipoproteins', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in total cholesterol and lipoproteins, such as low-density lipoprotein and high-density lipoprotein'}, {'measure': 'Changes in levels of apolipoproteins', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in levels of apolipoproteins, i.e. apo A1, apo B, apo B-48 and apo C-III'}, {'measure': 'Changes in levels of free fatty acids', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Changes in levels of circulating inflammatory markers', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in levels of inflammatory markers, such as cytokines, acute phase proteins and soluble adhesion molecules'}, {'measure': 'Changes in levels of circulating endotoxins', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Changes in gene expressions (mRNA and microRNA) of genes related to lipid metabolism and inflammation in Peripheral Blood Mononuclear Cells (PBMC)', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Changes in whole genome transcriptomics in PBMC', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Check DNA for Single Nucleotide Polymorphisms related to responses of a high-fat meal', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}, {'measure': 'Examine epigenetics through DNA methylation and histone modification', 'timeFrame': 'Measured at baseline and 6 hours after intake of test meal'}, {'measure': 'Changes of plasma and urine metabolomics', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in levels of metabolites, such as glucose and amino acids'}, {'measure': 'Changes in levels of gut hormones', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal', 'description': 'Changes in levels of gut hormones, such as peptide YY (PYY)'}, {'measure': 'Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire', 'timeFrame': 'Measured at baseline and 2,4 and 6 hours after intake of test meal'}]}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'Obese Volunteers'], 'conditions': ['Healthy', 'Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '31208475', 'type': 'DERIVED', 'citation': 'Hansson P, Holven KB, Oyri LKL, Brekke HK, Gjevestad GO, Thoresen M, Ulven SM. Sex differences in postprandial responses to different dairy products on lipoprotein subclasses: a randomised controlled cross-over trial. Br J Nutr. 2019 Oct 14;122(7):780-789. doi: 10.1017/S0007114519001429.'}, {'pmid': '30759235', 'type': 'DERIVED', 'citation': 'Hansson P, Holven KB, Oyri LKL, Brekke HK, Biong AS, Gjevestad GO, Raza GS, Herzig KH, Thoresen M, Ulven SM. Meals with Similar Fat Content from Different Dairy Products Induce Different Postprandial Triglyceride Responses in Healthy Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2019 Mar 1;149(3):422-431. doi: 10.1093/jn/nxy291.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to elucidate how high-fat meals with different kinds of dairy products affect postprandial responses of lipid metabolism and inflammatory markers in healthy and obese subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include both men and women aged 18-70 years with the aim of an even age and gender balance.\n* Participants in the healthy group will need to have a body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference (WC) of \\<94 cm for men and\\<80 cm for women.\n* Participants in the obese group will need to have a BMI of ≥25 kg/m2 and a waist circumference of ≥94 cm for men and ≥80 cm for women.\n* All subjects must be willing to eat three slices of bread with a dairy product and jam as breakfast.\n\nExclusion Criteria:\n\n* BMI \\<18.5 kg/m2 or \\>25 kg/m2 in the healthy group and \\<25 kg/m2 in the obese group\n* WC ≥94 for men and ≥80 cm for women in the healthy group, \\<94/80 cm for men/women in the obese group\n* Weight change of ± 5 % of body weight in the last three months\n* TG ≥1.3 mmol/L in the healthy group\n* CRP \\>10 mg/L\n* Total cholesterol \\>6.1 mmol/L for subjects 18-29 years, \\>6.9 mmol/L for subjects 30-49 years and \\>7.8 mmol/L for subjects ≥50 years old\n* Blood pressure \\>160/100 mm Hg\n* Comorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), coronary heart disease, haemophilia, anaemia (hemoglobin \\<120 gram/L), gastro intestinal disease and hyperthyroidism (TSH \\>4 mU/L)\n* Pregnant or lactating\n* Allergic or intolerant to gluten, milk protein and/or lactose\n* Use of medications affecting lipid metabolism or inflammation\n* Unwilling to seponate omega-3 rich supplements four weeks prior to screening and during the study period\n* Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)\n* Blood donation two months prior to test day 1 or during the study period\n* Tobacco smoking\n* Excessive regular alcohol consumption (\\>40 grams per day) or prior to the test day'}, 'identificationModule': {'nctId': 'NCT02836106', 'briefTitle': 'Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation in Healthy and Obese Subjects', 'orgStudyIdInfo': {'id': '2016/418/REK sør-øst B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy', 'description': 'Lean subjects (BMI\\<25) with a waist circumference of \\<94 cm for men and\\<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.', 'interventionNames': ['Other: Butter', 'Other: Cheese', 'Other: Whipped cream', 'Other: Sour cream']}, {'type': 'EXPERIMENTAL', 'label': 'Obese', 'description': 'Overweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.', 'interventionNames': ['Other: Butter', 'Other: Cheese', 'Other: Whipped cream', 'Other: Sour cream']}], 'interventions': [{'name': 'Butter', 'type': 'OTHER', 'description': 'Butter with jam and three slices of bread', 'armGroupLabels': ['Healthy', 'Obese']}, {'name': 'Cheese', 'type': 'OTHER', 'description': 'Cheese with jam and three slices of bread', 'armGroupLabels': ['Healthy', 'Obese']}, {'name': 'Whipped cream', 'type': 'OTHER', 'description': 'Whipped cream with jam and three slices of bread', 'armGroupLabels': ['Healthy', 'Obese']}, {'name': 'Sour cream', 'type': 'OTHER', 'description': 'Sour cream with jam and three slices of bread', 'armGroupLabels': ['Healthy', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Stine M Ulven, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tine', 'class': 'INDUSTRY'}, {'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stine Marie Ulven', 'investigatorAffiliation': 'University of Oslo'}}}}