'Study on infant Adiposity development To Understand the Role of early life Nutrition - the Sophia Saturn Study'

Breastfeeding is considered as the gold standard for infant nutrition. Human
milk is the optimal source of nutrients for the growth of infants in the first
months of life. It provides the best nutritional components delivered in the
most efficient way and it conveys the best immunologic protection from a
healthy mother to her child. This is established by the optimal composition of
the macronutrients and micronutrients. Breastfeeding results in short term
positive nutritive and developmental effects, but also in long term benefits.
Among the short term beneficial effects are the development of the immune
system and the colonization and establishment of the gut microbiota, whereas in
the long term breastfeeding has been shown to protect for the prevalence of
overweight or obesity.
Unfortunately, breastfeeding is not always possible or desirable and then
infant formula is the best alternative solution. The scientific community has
been striving to better understand the properties and composition of human
milk, the fate of its ingested nutrients, the regulation of digestion, and as a
result is learning which nutrient quantities and formats are preferable and
available for absorption and deposition into tissues and leading to optimal
growth and development. This acquired knowledge is continuously being
incorporated into the further improvement of infant milk formulas.
An innovative infant formula concept has been developed in which, compared to
current standard formula, the lipid quality and structure have been improved,
resulting in lipid droplets closer to those present in human milk (Nuturis®).
In two randomized, controlled, double-blind, multi-country trials, Nuturis® was
demonstrated to be well-tolerated, supporting adequate growth and being safe
for use in healthy term infants. Growth patterns in Nuturis®-fed infants were
more balanced and closer to the breastfed reference. However, the effect of
Nuturis® on infant body composition development was not investigated. Other
studies show a positive effect of breastfeeding on neurocognitive
function/intelligence compard to formula feeding. In the extension study, at
age 3, 4 and 5 years, we investigate if Nuturis feeding also shows a positive
effect on neurocognitive function/intelligence.

Primary Objective:
To investigate change in fat mass index between 6 and 12 months of age in
infants receiving Nuturis® formula feeding versus standard formula feeding
during the first 6 months of life.

Secondary Objectives:
- To investigate change in fat mass index over time in infants receiving
Nuturis® formula feeding or standard formula feeding during the first 6 months
of life, compared to a breastfed reference group.
To investigate effects on other body composition parameters (e.g. total fat
mass, fat mass percentage, subcutaneous and visceral fat mass) and
anthropometric measurements (e.g. weight, length, weight-for-length, BMI and
skinfolds SD) during the first 5 years of life.
- To explore associations of growth and body composition development with
maternal characteristics (e.g. pre-pregnancy BMI, smoking, excess gestational
weight gain), with metabolic biomarkers (e.g. serum lipids, satiety hormones)
and with eating behavior of infants receiving Nuturis® formula feeding versus
standard formula feeding and compared to a breastfed reference group.

A randomized, placebo-controlled, double-blind study to investigate the effect
of Nuturis® versus standard formula feeding on the longitudinal change in fat
mass index, when parents decided to start formula feeding in infants within 6
weeks after birth.

Intervention: Nuturis formula feeding, start within 6 weeks after birth until 6
months of age
Control: Standard formula feeding, start within 6 weeks after birth until 6
months of age

Subject will be included within 6 weeks after birth and will visit the Sophia
Children's Hospital at randomization, 3, 6, 9, 12, 18 and 24 months and at 3,4
and 5 years. In this period we will collect 9 blood samples. The total amount
of blood will be limited due to the use of special kits so that a few drops of
blood is enough. Blood collection will be conducted by trained staff.
At all visits, measurements such as anthropometrics and body composition will
be performed. Body composition will be measured by PEA POD, a validated,
non-invasive, safe device. From 6 months onwards, body composition will be
measured by DXA-scan, which gives very low radiation exposure (approximately
0.0002 mSv). Both body composition and growth measurements are safe and
non-invasive.