Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00378859
Status:
COMPLETED
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 Milk and Meat on IGFs in Prepubertal Boys
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose 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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2001-03'}, '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'}, {'measure': 'Aminogram'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure'}, {'measure': 'Kidney Size'}, {'measure': 'Urea Nitrogen'}, {'measure': 'Adiponectin'}, {'measure': 'Leptin'}, {'measure': 'Ghrelin'}, {'measure': 'Osteocalcin'}, {'measure': 'BAP'}, {'measure': 'CTX'}]}, 'conditionsModule': {'keywords': ['Children', 'Milk', 'Meat', 'Animal Protein', 'Growth Factors', 'IGF-I', 'IGFBP-3', 'Insulin'], 'conditions': ['Growth Disorders', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to examine whether a 7-day high protein intake from either milk or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.', 'detailedDescription': 'The objective of the study is to examine whether a high protein intake (PI) from either milk or meat, at a level often seen in late infancy, in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.\n\nIGF-I levels are positively associated with growth velocity in children and some studies suggest that a high animal PI can stimulate growth. During protein deprivation IGF-I decrease, but it is unknown whether a high PI can increase s-IGF-I in well-nourished children.\n\nInsulin is also a growth factor, and studies have found that postprandially, milk possess some insulinotrophic effect not related to its carbohydrate content. However, the effect on fasting insulin in children is unknown.\n\nDesign: Twenty-four 8-y-old boys are asked to take either 1.5 l of skimmed milk (n=12) or the same amount of protein as 250 g low fat meat (n=12) daily for seven days. The remaining diet they can choose freely. At baseline and after seven days, anthropometrical variables are measured, diet is registered (3-d weighed records), and the blood analytes are determined after fast.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* habital milk intake more than 500 mL/d\n* willing to increase intake of milk or meat considerably for one week\n\nExclusion Criteria:\n\n* chronic illnesses\n* children who suffer from any condition likely to affect their protein metabolism or growth'}, 'identificationModule': {'nctId': 'NCT00378859', 'briefTitle': 'The Effect of Milk and Meat on IGFs in Prepubertal Boys', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of Milk and Meat on IGFs in Prepubertal Boys', 'orgStudyIdInfo': {'id': 'KF 01-097/00'}, 'secondaryIdInfos': [{'id': 'D-110'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Skim milk', 'type': 'BEHAVIORAL'}, {'name': 'Lean meat', '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'}}}}