Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT00378820
Status:
UNKNOWN
Last Update Posted:
2009-01-21
First Post:
2006-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Whey and Casein on IGFs in Prepubertal Boys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2006-09-20', 'studyFirstSubmitQcDate': '2006-09-20', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IGF-I'}, {'measure': 'IGFBP-3'}, {'measure': 'Insulin'}, {'measure': 'Glucose'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure'}, {'measure': 'Body Composition'}, {'measure': 'Adiponectin'}, {'measure': 'Leptin'}, {'measure': 'Ghrelin'}, {'measure': 'C-peptide'}, {'measure': 'OGGT'}, {'measure': 'Urea Nitrogen'}, {'measure': 'Amino Acids'}, {'measure': 'Osteocalcin'}, {'measure': 'BAP'}, {'measure': 'CTX'}]}, 'conditionsModule': {'keywords': ['Children', 'Whey', 'Casein', 'Milk minerals', 'Growth factors', 'IGF-I', 'Insulin'], 'conditions': ['Metabolic Syndrome', 'Obesity']}, 'descriptionModule': {'briefSummary': 'It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure.', 'detailedDescription': 'Milk has evolved to support high growth velocity in newborns and observational and intervention studies suggest that milk has special growth stimulating properties especially regarding body size, bone mass and gut. We have previously shown that a one week high-dose intervention with milk, but not meat, increased fasting IGF-I and insulin levels in prepubertal boys. It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure. Exploring the growth stimulating effects of these milk components will improve the understanding of dietary effects on growth and bone metabolism, and will be valuable for the diary industry developing dietary products supporting growth e.g. infant formula, products for clinical nutrition and milk based products for nutritional rehabilitation of malnourished children in developing countries.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* habital milk intake:200 - 500 mL/d\n\nExclusion Criteria:\n\n* chronic illnesses\n* children who suffer from any condition likely to affect their protein metabolism or growth'}, 'identificationModule': {'nctId': 'NCT00378820', 'briefTitle': 'The Effect of Whey and Casein on IGFs in Prepubertal Boys', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys', 'orgStudyIdInfo': {'id': 'KF 01-072/04'}, 'secondaryIdInfos': [{'id': 'D-111'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Whey without milk minerals', 'type': 'BEHAVIORAL'}, {'name': 'Whey with milk minerals', 'type': 'BEHAVIORAL'}, {'name': 'Casein without milk minerals', 'type': 'BEHAVIORAL'}, {'name': 'Casein with milk minerals', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Institute of Human Nutrition, Rolighedsvej 30'}], 'overallOfficials': [{'name': 'Kim F Michaelsen, Dr Med Sci', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'ARLA Ingredients a.m.b.a.', 'class': 'UNKNOWN'}]}}}