Clinical trial NCT00378820: The Effect of Whey and Casein on IGFs in Prepubertal Boys
Official title: The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: Children
Whey
Casein
Milk minerals
Growth factors
IGF-I
Insulin
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: ARLA Ingredients a.m.b.a.
First posted: 2006-09-21
Enrollment: 60
Sex: MALE
Minimum age (years): 8
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* habital milk intake:200 - 500 mL/d

Exclusion Criteria:

* chronic illnesses
* children who suffer from any condition likely to affect their protein metabolism or growth

Primary outcomes:
measure: IGF-I
measure: IGFBP-3
measure: Insulin
measure: Glucose
Secondary outcomes:
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
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Institute of Human Nutrition, Rolighedsvej 30
Study officials:
affiliation: Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
name: Kim F Michaelsen, Dr Med Sci
role: STUDY_CHAIR
References: