Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-29 @ 4:06 AM
Study NCT ID:
NCT01773304
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2013-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-22', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'weight', 'timeFrame': 'at baseline at both visits'}, {'measure': 'height', 'timeFrame': 'at baseline at the first visit'}], 'primaryOutcomes': [{'measure': 'serum C-terminal carboxy-terminal collagen crosslinks (CTX)', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'urine C-terminal carboxy-terminal collagen', 'timeFrame': 'baseline 24-h urine samples and 24-h urine samples after the meal test at both visits'}, {'measure': 'serum osteocalcin (sOC)', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'serum tartrate-resistant acid phosphatase (s-TRAP)', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'urine deoxypyridinoline crosslink (uDPD)', 'timeFrame': 'baseline 24-h urine samples and 24-h urine samples after the meal test at both visits'}, {'measure': 'plasma metabolites for metabolomics analyses', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'urine metabolites for metabolomics analyses', 'timeFrame': 'baseline 24-h urine samples, 24-h urine samples after the meal test, urine samples at 2-h and 4-h after the meal test and urine samples from 4-h to 24-h, all at both visits'}], 'secondaryOutcomes': [{'measure': 'serum insulin-growth factor-1 (IGF-1)', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'serum insulin-growth factor binding-protein-3 (IGFBP-3)', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'serum insulin', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'serum glucose', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'serum glukagon-like peptide-1 (GLP-1)', 'timeFrame': 'at 0, 30, 60, 120, 180 and 240 min at both visits'}, {'measure': 'urinary PABA', 'timeFrame': 'baseline 24-h urine samples and 24-h urine samples after the meal test at both visits'}, {'measure': 'urinary creatinin', 'timeFrame': 'baseline 24-h urine samples and 24-h urine samples after the meal test at both visits'}, {'measure': 'urinary biobank', 'timeFrame': 'baseline 24-h urine samples and 24-h urine samples after the meal test at both visits'}, {'measure': 'plasma biobank', 'timeFrame': 'at 0, 30, 60, 90, 120, 180 and 240 min at both visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Adults', 'Bone metabolism', 'Metabolic profile', 'Dairy protein', 'Meat protein'], 'conditions': ['Obesity', 'Bone Metabolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake. The results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females between 18 and 50 years\n* BMI 25-40\n\nExclusion Criteria:\n\n* Physical activity more than 10 hours weekly\n* Smoking\n* Diagnosed osteoporosis in at least one parent\n* Dietary supplements and vitamin pills (during the study and 2 months before the start)\n* Vegetarians and vegans\n* Lactose intolerant\n* Women who are pregnant, breastfeeding or post-menstrual\n* Regular intake of medication\n* Chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders)\n* Participation in other clinical trials that could affect the test results\n* Donation of blod within 3 months before intervention start\n* Hypersensitivity to paraaminobenzoic acid (PABA)\n* Not able to comply with the procedures established by the Protocol'}, 'identificationModule': {'nctId': 'NCT01773304', 'acronym': 'MEDA', 'briefTitle': 'Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults', 'orgStudyIdInfo': {'id': 'M210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal rich in dairy protein', 'interventionNames': ['Other: Dietary meal intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Meal rich in meat protein', 'interventionNames': ['Other: Dietary meal intervention']}], 'interventions': [{'name': 'Dietary meal intervention', 'type': 'OTHER', 'description': 'Test meals with different protein types (dairy versus meat)', 'armGroupLabels': ['Meal rich in dairy protein', 'Meal rich in meat protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Copenhagen', 'state': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Agriculture and Food Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Med Sci', 'investigatorFullName': 'AAstrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}