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
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
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
NCT ID
NCT00379171
First Posted
September 20, 2006
Last Updated
August 13, 2008
Sponsor
University of Copenhagen
Collaborators
Anjo A/S
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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