Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01199835
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2010-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Dairy Products on Energy Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-10', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal fat excretion', 'timeFrame': '24 weeks'}, {'measure': 'Body weight', 'timeFrame': '24 weeks'}, {'measure': 'body composition', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Resting energy expenditure', 'timeFrame': '24 weeks'}, {'measure': 'Blood pressure', 'timeFrame': '24 weeks'}, {'measure': 'Appetite regulation', 'timeFrame': '24 weeks'}, {'measure': 'Lipid profile', 'timeFrame': '24 weeks'}, {'measure': 'Intestinal micro flora', 'timeFrame': '24 weeks'}, {'measure': 'Metabolomics in urine, feces and blood', 'timeFrame': '24 week'}, {'measure': 'calcium excretion', 'timeFrame': '24 weeks'}, {'measure': 'bone markers', 'timeFrame': '24 weeks'}, {'measure': 'vitamin D status', 'timeFrame': '24 weeks'}, {'measure': 'calcium status', 'timeFrame': '24 weeks'}, {'measure': 'lipid metabolism', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'keywords': ['obesity', 'metabolic syndrome', 'fecal fat excretion', 'fecal calcium', 'weight loss', 'appetite regulation', 'intestinal micro flora', 'lipid profile', 'energy balance'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women,\n* medium overweight (body mass index 28-36 kg/m2),\n* 18-60 years old,\n* low habitual calcium intake (\\<800 mg/d)\n\nExclusion Criteria:\n\n* milk allergy, infection diseases and diabetes,\n* intake of dietary supplements,\n* smoking,\n* pregnancy and/or breast feeding,\n* any medications known to affect the outcome measurements,\n* weigh reducing diet,\n* gastrointestinal diseases,\n* participation in other intervention studies'}, 'identificationModule': {'nctId': 'NCT01199835', 'acronym': 'MEPEB', 'briefTitle': 'The Effects of Dairy Products on Energy Balance', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effects of Dairy Products on Energy Balance', 'orgStudyIdInfo': {'id': 'B251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high calcium', 'description': 'Dietary intake of calcium \\~ 1500 mg/ d, including \\~1200 mg/d from dairy products', 'interventionNames': ['Other: High Calcium intake from dairy products']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low calcium', 'description': 'Low dietary intake of calcium, i.e. \\~ \\<600 mg/d, including 0-1 portion of dairy products', 'interventionNames': ['Other: High Calcium intake from dairy products']}], 'interventions': [{'name': 'High Calcium intake from dairy products', 'type': 'OTHER', 'description': 'High dietary intake of calcium from dairy products (\\~1200 mg/d)', 'armGroupLabels': ['Low calcium', 'high calcium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}, {'name': 'The Danish Dairy Research Foundation, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Human Nutrition', 'investigatorFullName': 'Arne Astrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}