Cardiovascular Disease, Growth, Metabolic Syndrome, Obesity
Conditions
Keywords
n-3 LCPUFA, Fish oil, essential fatty acids, infant growth, obesity, Intestinal microbiota
Brief summary
The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.
Interventions
DIETARY_SUPPLEMENTFish Oil
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
DIETARY_SUPPLEMENTSunflower Oil
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Sponsors
Axellus
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Months to 19 Months
Healthy volunteers
Yes
Inclusion criteria
* Singleton infants, 9 mo +/- 2 wk, born \>= 37 wk of gestation * Birth weight \>=2500g, a 5-min Apgar score \>= 7, birth weight \>= 5th percentile for gestational age
Exclusion criteria
* Chronic diseases expected to influence growth and dietary intake * Use of medicine expected to influence growth and dietary intake * Fish oil supplementation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth | — |
| IGF-1 and IGFBP-3 | — |
| Adipokines | — |
| Plasma CRP | — |
| Plasma IgE | — |
| Body composition | — |
| Intestinal microbiota | — |
| Blood pressure | — |
| Plasma lipid profile | — |
| Insulin - glucose | — |
| Erythrocyte fatty acid composition | — |
| Ex vivo cytokine production | — |
Secondary
| Measure | Time frame |
|---|---|
| Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing) | — |
| Iron status (hemoglobin, ferritin) | — |
| faecal calprotectin | — |
| FADS1 and FADS2 genotypes | — |
| Allergy status | — |
| Glucagon | — |
Countries
Denmark
Outcome results
None listed