Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT01472666
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2011-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067796', 'term': 'Whey'}, {'id': 'D002364', 'term': 'Caseins'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010750', 'term': 'Phosphoproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-29', 'studyFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial triglyceride response', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Compare the changes in mean difference of 6 hours incremental area under the curve (iAUC) (week 12 - week 0) between the groups and the intervention components.'}], 'secondaryOutcomes': [{'measure': '24 hour blood pressure (BP)', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Spacelabs, model 90207/90217, USA'}, {'measure': 'Indirect calorimetry', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Measured 2 times during meal test.'}, {'measure': 'Dexa-scan (body composition)', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.'}, {'measure': 'Weight', 'timeFrame': 'Change from week 0 to week 12'}, {'measure': 'Biomarkers in blood samples', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Glucose, insulin, glucagon, HbA1c. free fatty acids, Lipid profile (total-cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride). Inflammations markers (interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 receptor antagonist (IL-1RA), interleukin-1 beta (IL-1b), high sensitive c-reactive protein (hs-CRP), adiponectin, monocyte chemoattractant protein-1 (MCP-1), Rantes (CCL5)). Incretins (GLP-1, GIP). Nutrigenomics. Metabolomics. Proteomics.'}, {'measure': 'Waist and hip circumference', 'timeFrame': 'Change from week 0 to week 12'}, {'measure': 'Fat tissue biopsy', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Fat tissue gene expression. Twice during meal test.'}, {'measure': 'Biomarkers in urine', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Nutrigenomics and metabolomics'}, {'measure': 'Glucose tolerance', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Oral glucose tolerance test (OGTT) (with insulin and glucose measurement at time -15 min, -10 min, 0 min, 30 min, 60 min, and 120 min). Hereby calculating the homeostatic model assessment of insulin resistance (HOMA-IR) and the Matsuda index.'}, {'measure': 'Dietary compliance', 'timeFrame': 'Change from week 0 to week 12', 'description': '3-day food diary.'}, {'measure': 'Postprandial apolipoprotein-48 (apoB-48), 6 hour', 'timeFrame': 'Change from week 0 to week 12', 'description': 'Meal test, blood samples at time 0,2,4 and 6 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medium chain fatty acids', 'Saturated fatty acids', 'Whey protein', 'Casein protein', 'Metabolic syndrome', 'Type 2 diabetes', 'Cardiovascular disease', 'Dairy products', 'Dietary intervention'], 'conditions': ['Metabolic Syndrome', 'Type 2 Diabetes', 'Cardiovascular Disease', 'Abdominal Obesity']}, 'referencesModule': {'references': [{'pmid': '25833983', 'type': 'DERIVED', 'citation': "Bohl M, Bjornshave A, Rasmussen KV, Schioldan AG, Amer B, Larsen MK, Dalsgaard TK, Holst JJ, Herrmann A, O'Neill S, O'Driscoll L, Afman L, Jensen E, Christensen MM, Gregersen S, Hermansen K. Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. Am J Clin Nutr. 2015 Apr;101(4):870-8. doi: 10.3945/ajcn.114.097923. Epub 2015 Jan 14."}]}, 'descriptionModule': {'briefSummary': "Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and in particular whey proteins have been shown to have a beneficial effect on glucose disposal as well as anti-inflammatory properties. Therefore dairy products have a potential role in the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data from intervention studies are lacking.\n\nAims of this project is to explore and understand the influence on human health of both medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well as their interaction and potential positive synergy on the MeS.\n\nThe investigators hypothesize that whey protein and medium-chain saturated fatty acids improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory stress in humans and that they possess preventive effects on the risk of developing CVD and type 2 diabetes mellitus (T2DM).\n\nA total of 64 people with MeS or abdominal obesity will be included. The design is a randomized double-blinded, controlled parallel diet-intervention trial.\n\nSubjects are assigned one of four experimental diets for 12 weeks. The diets consist of either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA + whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to integrate the test foods in their habitual diet, which also continues unchanged. The subjects' energy intake is matched so they are kept weight stable throughout the study.", 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMetabolic syndrome\n\n* Central obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)\n* with two or more of the following\n* Fasting triglyceride \\> 1.7 mmol/l\n* HDL-cholesterol; male \\< 1.03 mmol/l, female \\< 1.29 mmol/l\n* BP ≥ 130/85\n* Fasting plasma glucose ≥ 5,6 mmol/l (but not diabetes)\n\nOr abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)\n\nExclusion Criteria:\n\n* Significant cardiovascular, renal or endocrine disease\n* Psychiatric history\n* Treatment with steroids\n* Alcohol- or drug-addiction\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01472666', 'briefTitle': 'Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"', 'orgStudyIdInfo': {'id': 'CERN-DairyHealth'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fat rich in MC-SFA', 'description': '63 gram milk fat with high content of MC-SFA (C6-C12=8.5 g) incorporated in rolls, muffin and as butter.', 'interventionNames': ['Dietary Supplement: High content of MC-SFA']}, {'type': 'EXPERIMENTAL', 'label': 'Fat low on MC-SFA', 'description': '63 gram milkfat with low content of MC-SFA (C6-C12=6.9 g) incorporated in rolls, muffin and as butter', 'interventionNames': ['Dietary Supplement: Low content of MC-SFA']}, {'type': 'EXPERIMENTAL', 'label': 'Casein protein', 'description': '60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water.', 'interventionNames': ['Dietary Supplement: Casein']}, {'type': 'EXPERIMENTAL', 'label': 'Whey protein', 'description': '60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water.', 'interventionNames': ['Dietary Supplement: Whey']}], 'interventions': [{'name': 'High content of MC-SFA', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks dietary intervention', 'armGroupLabels': ['Fat rich in MC-SFA']}, {'name': 'Whey', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks dietary intervention', 'armGroupLabels': ['Whey protein']}, {'name': 'Low content of MC-SFA', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks dietary intervention', 'armGroupLabels': ['Fat low on MC-SFA']}, {'name': 'Casein', 'type': 'DIETARY_SUPPLEMENT', 'description': '12 weeks dietary intervention', 'armGroupLabels': ['Casein protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Kjeld Hermansen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Hanne C Bertram, Scientist', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Food Science, University of Aarhus'}, {'name': "Lorraine O'Driscoll, Professor", 'role': 'STUDY_CHAIR', 'affiliation': 'School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland'}, {'name': 'Michael Müller, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Human Nutrition, Wageningen University, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Arla Foods', 'class': 'INDUSTRY'}, {'name': 'Wageningen University', 'class': 'OTHER'}, {'name': 'University of Dublin, Trinity College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}