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

Primary Purpose

Obesity, Metabolic Syndrome, Growth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cow's milk with fish oil
Cow's milk without fish oil
Formula with fish oil
Formula without fish oil
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Children, Complementary feeding, Breast feeding, Cow's milk, Formula, Protein, LCPUFA, Fish oil, Lipid profile, Intestinal inflammation, Intestinal microbiota

Eligibility Criteria

8 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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
    Heart Rate Variability (HRV)
    In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
    Plasma IgE, IL-2R, and CRP

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 20, 2006
    Last Updated
    August 13, 2008
    Sponsor
    University of Copenhagen
    Collaborators
    Anjo A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00379171
    Brief Title
    Milk Types and Fish Oil in 9- to 12-Month-Old Infants
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Copenhagen
    Collaborators
    Anjo A/S

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Metabolic Syndrome, Growth, Blood Pressure, Cardiovascular Disease
    Keywords
    Children, Complementary feeding, Breast feeding, Cow's milk, Formula, Protein, LCPUFA, Fish oil, Lipid profile, Intestinal inflammation, Intestinal microbiota

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Cow's milk with fish oil
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cow's milk without fish oil
    Intervention Type
    Behavioral
    Intervention Name(s)
    Formula with fish oil
    Intervention Type
    Behavioral
    Intervention Name(s)
    Formula without fish oil
    Primary Outcome Measure Information:
    Title
    Growth
    Title
    Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
    Title
    IGF-I
    Title
    IGFBP-3
    Title
    Insulin - glucose metabolism (HOMA index).
    Title
    Urea Nitrogen
    Title
    Albumin
    Title
    C-peptide
    Title
    Amino Acids
    Title
    Erythrocyte fatty acid composition
    Title
    Blood pressure
    Title
    Lipid Profile
    Title
    Heart Rate Variability (HRV)
    Title
    In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
    Title
    Plasma IgE, IL-2R, and CRP
    Secondary Outcome Measure Information:
    Title
    Plasma concentrations of cholesterol and triglycerides
    Title
    Allergy status
    Title
    Cognitive test ("The infant means-end problem solving test")
    Title
    Iron status (hemoglobin, ferritin and transferrin receptors)
    Title
    Feces samples: Calprotectin, IgA and composition of the intestinal microbiota

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Months
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kim F Michaelsen, Dr Med Sci
    Organizational Affiliation
    Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18679165
    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.
    Results Reference
    result
    PubMed Identifier
    17460496
    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. doi: 10.1097/MPG.0b013e3180406a11.
    Results Reference
    result
    PubMed Identifier
    17374672
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    16365065
    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. doi: 10.1093/jn/136.1.94.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Citation&list_uids=16365065
    Description
    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.

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

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