Milk Types and Fish Oil in 9- to 12-Month-Old Infants

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379171
• Other study ID #: KF 02-014/03
• Secondary ID: D-74
• Status: Completed
• Phase: N/A
• First received: September 20, 2006
• Last updated: August 13, 2008
• Start date: May 2003
• Est. completion date: March 2004

Study information

• Verified date: August 2008
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Months to 12 Months

Eligibility

Inclusion Criteria:

• Singleton infants

• Born >= 37 wk of gestation

• Birth weight > 2500g

• >= 5th percentile for gestational age

• A 5-min Apgar score >= 7

• Daily consumption of cow's milk or formula

Exclusion Criteria:

• No major complications at birth or in fetal life

• No chronic diseases

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Disease
• Cardiovascular Diseases
• Growth
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Cow's milk with fish oil

• Cow's milk without fish oil

• Formula with fish oil

• Formula without fish oil

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Anjo A/S

References & Publications (4)

Damsgaard CT, Lauritzen L, Kjaer TM, Holm PM, Fruekilde MB, Michaelsen KF, Frøkiaer H. Fish oil supplementation modulates immune function in healthy infants. J Nutr. 2007 Apr;137(4):1031-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth
Primary	Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
Primary	IGF-I
Primary	IGFBP-3
Primary	Insulin - glucose metabolism (HOMA index).
Primary	Urea Nitrogen
Primary	Albumin
Primary	C-peptide
Primary	Amino Acids
Primary	Erythrocyte fatty acid composition
Primary	Blood pressure
Primary	Lipid Profile
Primary	Heart Rate Variability (HRV)
Primary	In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
Primary	Plasma IgE, IL-2R, and CRP
Secondary	Plasma concentrations of cholesterol and triglycerides
Secondary	Allergy status
Secondary	Cognitive test ("The infant means-end problem solving test")
Secondary	Iron status (hemoglobin, ferritin and transferrin receptors)
Secondary	Feces samples: Calprotectin, IgA and composition of the intestinal microbiota

External Links

•   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;136:94-9.