- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00378859
The Effect of Milk and Meat on IGFs in Prepubertal Boys
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
IGF-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.
Insulin 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.
Design: 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.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Frederiksberg C, Danmark, 1958
- Institute of Human Nutrition, Rolighedsvej 30
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- habital milk intake more than 500 mL/d
- willing to increase intake of milk or meat considerably for one week
Exclusion Criteria:
- chronic illnesses
- children who suffer from any condition likely to affect their protein metabolism or growth
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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IGF-I
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IGFBP-3
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Insulin
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Glukose
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Aminogram
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Sekundære resultatmål
Resultatmål |
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Urea nitrogen
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Blodtryk
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Adiponectin
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Leptin
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Ghrelin
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Osteocalcin
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BAP
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CTX
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Kidney Size
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Kim F Michaelsen, Dr Med Sci, Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KF 01-097/00
- D-110
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