Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-29 @ 2:30 PM
Study NCT ID:
NCT01317251
Status:
COMPLETED
Last Update Posted:
2014-09-05
First Post:
2011-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-04', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal fat excretion', 'timeFrame': 'During day 10-14 in each period', 'description': 'Total excretion of fecal fat (grams/day)avaraged over five days'}], 'secondaryOutcomes': [{'measure': 'Total, HDL and LDL cholesterol', 'timeFrame': 'Day 1 and 14 in each period'}, {'measure': 'Triglycerides', 'timeFrame': 'Day 1 and 14 in each period'}, {'measure': 'Appetite sensation', 'timeFrame': 'Assessed on day 1, 8 and 14 in each period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity prevention', 'appetite regulation', 'hyperlipidemia'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24622806', 'type': 'DERIVED', 'citation': 'Soerensen KV, Thorning TK, Astrup A, Kristensen M, Lorenzen JK. Effect of dairy calcium from cheese and milk on fecal fat excretion, blood lipids, and appetite in young men. Am J Clin Nutr. 2014 May;99(5):984-91. doi: 10.3945/ajcn.113.077735. Epub 2014 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* BMI 20-28 mg/m2\n\nExclusion Criteria:\n\n* Smoking\n* Medicine use\n* Dietary supplements\n* Lactose intolerance, milk allergy\n* Dislike of dairy products\n* Excessive physical activity (\\> 10h/wk)\n* Known chronic illnesses'}, 'identificationModule': {'nctId': 'NCT01317251', 'acronym': 'MOFF', 'briefTitle': 'Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid', 'orgStudyIdInfo': {'id': 'B281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control diet', 'description': 'Diet without dairy products', 'interventionNames': ['Other: Dietary intervention (without dairy products)']}, {'type': 'EXPERIMENTAL', 'label': 'Milk diet', 'description': 'Diet with a high content of milk', 'interventionNames': ['Other: Dietary intervention (high milk content)']}, {'type': 'EXPERIMENTAL', 'label': 'Cheese diet', 'description': 'Diet with a high content of cheese', 'interventionNames': ['Other: Dietary intervention (high cheese content)']}], 'interventions': [{'name': 'Dietary intervention (without dairy products)', 'type': 'OTHER', 'description': 'Control diet without dairy products', 'armGroupLabels': ['Control diet']}, {'name': 'Dietary intervention (high milk content)', 'type': 'OTHER', 'description': 'Diet with a high content of milk (\\~1200 mg Ca/d from milk)', 'armGroupLabels': ['Milk diet']}, {'name': 'Dietary intervention (high cheese content)', 'type': 'OTHER', 'description': 'Diet with a high content of cheese (\\~1200 mg Ca/d from cheese)', 'armGroupLabels': ['Cheese diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, University of Copenhagen'}], 'overallOfficials': [{'name': 'Arne Astrup, Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mette Kristensen', 'oldOrganization': 'University of Copenhagen'}}}}