Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-06 @ 4:57 AM
Study NCT ID:
NCT03656367
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the characteristics of the study design, blinding of project personnel and participants is not possible. However, statistical analyses of the results will be performed in a blinded fashion.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2018-08-31', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Paracetamol', 'timeFrame': '0-8 hour', 'description': 'Gastric emptying rate is evaluated by paracetamol (measured as fasting and postprandial concentrations after intake of a test meal).'}, {'measure': 'Metabolomics', 'timeFrame': '0-8 hour', 'description': 'Detailed absorption kinetics will be evaluated by NMR-based metabolomics'}, {'measure': 'Subjective appetite sensation', 'timeFrame': '0-8 hour', 'description': 'Subjective appetite sensation (e.g. hunger, satiety, thirst) will be evaluated by visual analogue scales (VAS). The VAS is a line (100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating of the subject\'s sensations. For example, Q: "How hungry do you feel now?", rating: "not at all" (=0 mm) and "extremely" (=100 mm)'}, {'measure': 'Acute energy intake', 'timeFrame': '8 hours after test meal', 'description': 'Acute energy intake is evaluated by energy intake of an ad libitum meal that is served after the 8-hour test meal period'}, {'measure': 'Appetite hormones', 'timeFrame': '0-8 hour', 'description': 'Fasting and postprandial concentrations of appetite hormones (e.g. GLP-1) may be measured after intake of a test meal.'}, {'measure': 'detailed metabolomics', 'timeFrame': '0-8 hour', 'description': 'Detailed absorption kinetics will be evaluated by LCMS-based metabolomics'}], 'primaryOutcomes': [{'measure': 'Triglyceride', 'timeFrame': '0-8 hour', 'description': 'The sample size is calculated on this endpoint. Fasting and postprandial concentrations of triglycerides (mmol/L) are measured after intake of a test meal.'}, {'measure': 'Apolipoprotein B48', 'timeFrame': '0-8 hour', 'description': 'Co-primary endpoint. Fasting and postprandial concentrations of apolipoprotein B48 are measured after intake of a test meal.'}], 'secondaryOutcomes': [{'measure': 'Cholesterol (total, LDL and HDL cholesterol)', 'timeFrame': '0-8 hour', 'description': 'Fasting and postprandial concentrations of cholesterol (mmol/L) are measured after intake of a test meal.'}, {'measure': 'Free Fatty Acid (FFA)', 'timeFrame': '0-8 hour', 'description': 'Fasting and postprandial concentrations of FFA (umol/L) are measured after intake of a test meal.'}, {'measure': 'Insulin', 'timeFrame': '0-8 hour', 'description': 'Fasting and postprandial concentrations of insulin (pmol/L) are measured after intake of a test meal.'}, {'measure': 'Glucose', 'timeFrame': '0-8 hour', 'description': 'Fasting and postprandial concentrations of glucose (mmol/L) are measured after intake of a test meal.'}, {'measure': 'Apolipoproteins', 'timeFrame': '0-8 hour', 'description': 'Fasting and postprandial concentrations of apolipoproteins (e.g. B100) are measured after intake of a test meal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glycaemia', 'insulinemia', 'lipaemia', 'appetite'], 'conditions': ['Lipaemia']}, 'referencesModule': {'references': [{'pmid': '34477812', 'type': 'RESULT', 'citation': 'Kjolbaek L, Schmidt JM, Rouy E, Jensen KJ, Astrup A, Bertram HC, Hammershoj M, Raben A. Matrix structure of dairy products results in different postprandial lipid responses: a randomized crossover trial. Am J Clin Nutr. 2021 Nov 8;114(5):1729-1742. doi: 10.1093/ajcn/nqab220.'}, {'pmid': '34357348', 'type': 'RESULT', 'citation': 'Thogersen R, Lindahl IEI, Khakimov B, Kjolbaek L, Juhl Jensen K, Astrup A, Hammershoj M, Raben A, Bertram HC. Progression of Postprandial Blood Plasma Phospholipids Following Acute Intake of Different Dairy Matrices: A Randomized Crossover Trial. Metabolites. 2021 Jul 14;11(7):454. doi: 10.3390/metabo11070454.'}, {'pmid': '32500911', 'type': 'RESULT', 'citation': 'Schmidt JM, Kjolbaek L, Jensen KJ, Rouy E, Bertram HC, Larsen T, Raben A, Astrup A, Hammershoj M. Influence of type of dairy matrix micro- and macrostructure on in vitro lipid digestion. Food Funct. 2020 Jun 24;11(6):4960-4972. doi: 10.1039/d0fo00785d.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to investigate how dairy products with different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry.\n\nThe study will be conducted as a randomized acute cross-over meal study. Apparently healthy men will be recruited in the study. They will on 4 test days consume the 4 dairy products and blood will be drawn the following 8 hours.', 'detailedDescription': 'The overall aim of this study is to investigate how dairy products with similar nutrient content but different structures and textures affect lipid absorption kinetics in the acute postprandial period via blood lipid biochemistry, as well as nuclear magnetic resonance (NMR) and liquid chromatography mass spectrometry (LCMS)-based metabolomics.\n\nThe study will be conducted as a randomized acute cross-over meal study. On four different test days (with a minimum of 2 weeks washout period) four dairy products with similar nutrient composition but different structures or textures will be tested. During each meal test a single dairy product (+ bread and water) is served and postprandial blood samples are collected the following 8 hours. Subjective appetite measurements (VAS) are filled in during the 8-hour period and an ad libitum meal is served in the end of the day.\n\n25 apparently healthy men (weight stable, 18-40 years, 18.5-24.9 kg/m2) will be recruited.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Apparently healthy men\n* 18-40 years of age\n* Body mass index (BMI): 18.5-24.9 kg/m\\^2\n* Non-smoker\n* Haemoglobin concentration ≥8.4 mmol/L\n\nExclusion Criteria:\n\n* Dislike for dairy products such as milk, cheese and yoghurt\n* Weight change \\>3 kg 2 months prior to study\n* Any other blood donation \\< 3 month prior to study and during study, than the blood donation that is included in this study\n* Intensive physical training (\\>10 hours of per week)\n* Self-reported eating disorders or irregular eating schedules (e.g. skipping breakfast) and uncommon diets (vegetarians, vegans etc.)\n* Alcohol intake above the recommendation from the Danish Health and Medicines Authority (\\>21 units of alcohol per week)\n* Night- or shift work\n* Food intolerance and allergies related to test products e.g. lactose and gluten\n* Dietary supplements, if not taken on a regular basis\n* Currently use, or use within previously 3 months of prescription medication, except non-prescription primary analgetica (NSAID and paracetamol) to relieve e.g. head ache and stomach pain, and glucocorticoider for topical use e.g. in ointment and creams.\n* Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, back pain, thyroid disease, heart disease, diabetes, inflammation\n* Disorders: neurological, sleep, diagnosed psychiatric disorder, and gastro intestinal and liver disorders.\n* Surgical treatment of obesity and abdominal surgery\n* Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible\n* Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible\n* Simultaneous participation in other clinical intervention studies"}, 'identificationModule': {'nctId': 'NCT03656367', 'acronym': 'DAIRYMAT', 'briefTitle': 'Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Designing Biofunctional Dairy Foods: Matrix Structure of Dairy Products in Relation to Lipaemia', 'orgStudyIdInfo': {'id': 'B346 (H-18024447)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'Cross-over study (all subjects receive all interventions)\n\n* Cheddar cheese\n* Blended and homogenized cheddar cheese\n* An analog milk\n* An analog cheese', 'interventionNames': ['Dietary Supplement: Cheddar cheese', 'Dietary Supplement: Blended and homogenized cheddar cheese', 'Dietary Supplement: An analog milk', 'Dietary Supplement: An analog cheese']}, {'type': 'OTHER', 'label': 'Healthy subjects only (subgroup)', 'description': 'If any subjects (against our hypothesis) have indices of metabolic syndrome i.e. raised fasting glucose or TG concentration, secondary analyses will be conducted to assess results without these subjects.\n\nAll subjects receive all interventions)\n\n* Cheddar cheese\n* Blended and homogenized cheddar cheese\n* An analog milk\n* An analog cheese', 'interventionNames': ['Dietary Supplement: Cheddar cheese', 'Dietary Supplement: Blended and homogenized cheddar cheese', 'Dietary Supplement: An analog milk', 'Dietary Supplement: An analog cheese']}], 'interventions': [{'name': 'Cheddar cheese', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The reference product is a commercial matured cheddar cheese', 'armGroupLabels': ['All subjects', 'Healthy subjects only (subgroup)']}, {'name': 'Blended and homogenized cheddar cheese', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet', 'armGroupLabels': ['All subjects', 'Healthy subjects only (subgroup)']}, {'name': 'An analog milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network', 'armGroupLabels': ['All subjects', 'Healthy subjects only (subgroup)']}, {'name': 'An analog cheese', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference', 'armGroupLabels': ['All subjects', 'Healthy subjects only (subgroup)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Anne B Raben, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anne Birgitte Raben', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Arla Foods', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Anne Birgitte Raben', 'investigatorAffiliation': 'University of Copenhagen'}}}}