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ObesityNCT00379171

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

A study testing Cow's milk with fish oil, Cow's milk without fish oil and Formula with fish oil in people with Obesity and Metabolic Syndrome, run by University of Copenhagen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 … Read more about this study

Who is it for?
Ages 8 to 12 monthsHealthy volunteers can take part
Conditions the study is for
Obesity, Metabolic Syndrome, Growth
What is being tested?
Cow's milk with fish oil, Cow's milk without fish oil and Formula with fish oil
How many people
100 participants
Where
No sites listed yet
Study dates
May 2003to Mar 2004
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • No major complications at birth or in fetal life
  • No chronic diseases

About this study

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

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.

Being tested
Cow's milk with fish oil, Cow's milk without fish oil, Formula with fish oil, Formula without fish oil
Keywords
Children, Complementary feeding, Breast feeding, Cow's milk, Formula, Protein, LCPUFA, Fish oil, Lipid profile, Intestinal inflammation, Intestinal microbiota
Medical subject headings
Obesity, Metabolic Syndrome, Cardiovascular Diseases, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cow's milk with fish oilBehavioural

  • Cow's milk without fish oilBehavioural

  • Formula with fish oilBehavioural

  • Formula without fish oilBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (5)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2006 (estimated)
  2. Study startMay 2003
  3. Study completionMar 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379171
Sponsor's protocol ID
KF 02-014/03
Other IDs
D-74
Status last verified
Aug 2008
First submitted
20 Sep 2006
Last updated
14 Aug 2008
Results posted
No

Publications

  • 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.

    PubMed 18679165

  • 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.

    PubMed 17460496

  • 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.

    PubMed 17374672

  • 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.

    PubMed 16365065

Questions about this trial

What is this clinical trial studying?

A study testing Cow's milk with fish oil, Cow's milk without fish oil and Formula with fish oil in people with Obesity and Metabolic Syndrome, run by University of Copenhagen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth. The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379171, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2008.

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