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OpenTrials
Completed

NCT Number: NCT00379171

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

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.

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Key information

Conditions

Obesity Behavior Blood Pressure Body Weight Breast Feeding Cardiovascular Disease Cardiovascular Diseases Feeding Behavior Glucose Metabolism Disorders Growth Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cow's milk with fish oil

Behavioral

Cow's milk without fish oil

Behavioral

Formula with fish oil

Behavioral

Formula without fish oil

Behavioral

Primary outcomes

  1. Growth

  2. Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).

  3. IGF-I

  4. IGFBP-3

  5. Insulin - glucose metabolism (HOMA index).

  6. Urea Nitrogen

  7. Albumin

  8. C-peptide

  9. Amino Acids

  10. Erythrocyte fatty acid composition

  11. Blood pressure

  12. Lipid Profile

  13. Heart Rate Variability (HRV)

  14. In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)

  15. Plasma IgE, IL-2R, and CRP

Secondary outcomes

  1. Plasma concentrations of cholesterol and triglycerides

  2. Allergy status

  3. Cognitive test ("The infant means-end problem solving test")

  4. Iron status (hemoglobin, ferritin and transferrin receptors)

  5. Feces samples: Calprotectin, IgA and composition of the intestinal microbiota

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Anjo A/S

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Sep 21, 2006
Registry last updated
Aug 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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