The Importance of Complementary Feeding on Growth, Nutritional Status and Markers for Disease. An Intervention Study With Milk Types and LC-PUFA Supplements in 9- to 12-Month-Old Infants
Sponsor study identifier
Secondary identifiers
interventional
100
0 countries
N/A
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
March 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2006
Actual (reported)September 21, 2006
Actual (reported)Growth
Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
IGF-I
IGFBP-3
Insulin - glucose metabolism (HOMA index).
Urea Nitrogen
Albumin
C-peptide
Amino Acids
Erythrocyte fatty acid composition
Blood pressure
Lipid Profile
Lauritzen L, Christensen JH, Damsgaard CT, Michaelsen KF. The effect of fish oil supplementation on heart rate in healthy Danish infants. Pediatr Res. 2008 Dec;64(6):610-4. doi: 10.1203/PDR.0b013e318186e5c5.
Nielsen S, Nielsen DS, Lauritzen L, Jakobsen M, Michaelsen KF. Impact of diet on the intestinal microbiota in 10-month-old infants. J Pediatr Gastroenterol Nutr. 2007 May;44(5):613-8. doi: 10.1097/MPG.0b013e3180406a11.
Kim F Michaelsen, Dr Med Sci
Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
First Submitted
September 20, 2006
First Posted
September 21, 2006
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
March 2004
Date type not reportedVasoprotective Activities of Low-Fat Milk in Individuals With Metabolic Syndrome
Heart Rate Variability (HRV)
In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
Plasma IgE, IL-2R, and CRP
Plasma concentrations of cholesterol and triglycerides
Allergy status
Cognitive test ("The infant means-end problem solving test")
Iron status (hemoglobin, ferritin and transferrin receptors)
Feces samples: Calprotectin, IgA and composition of the intestinal microbiota
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Damsgaard CT, Lauritzen L, Kjaer TM, Holm PM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation modulates immune function in healthy infants. J Nutr. 2007 Apr;137(4):1031-6. doi: 10.1093/jn/137.4.1031.
Damsgaard CT, Schack-Nielsen L, Michaelsen KF, Fruekilde MB, Hels O, Lauritzen L. Fish oil affects blood pressure and the plasma lipid profile in healthy Danish infants. J Nutr. 2006 Jan;136(1):94-9. doi: 10.1093/jn/136.1.94.
This date has not been verified as actual or estimated.
Last Updated
August 14, 2008
Record last verified: 2008-08
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Source: ClinicalTrials.gov.
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