The Sophia SATURN study; a randomized, controlled, double-blind clinical trial to study the impact of infant nutrition on early life body fat development.
The Sophia SATURN study (Study on infant Adiposity development To Understand the Role of early life Nutrition) is a randomized, controlled, double-blind investigator-initiated clinical trial.
The Sophia Saturn study is registered at the CCMO, with the registration number NL64048.078.18.
In the Sophia SATURN study, embedded in the Sophia PLUTO study cohort (see below for further details), the impact of Nuturis® on longitudinal infant body fat development is investigated.
The primary objective of the Sophia SATURN study is to assess the impact of Nuturis® on body fat development. The primary parameter is the change in fat mass index (fat mass/length2) from 6 to 12 months of age. Secondary outcomes include other body composition parameters and growth measurements during the first 2 years of life. In addition, associations of growth and body composition development with maternal characteristics, with metabolic biomarkers and with eating behavior will be explored.
During the first 1,000 days, infants undergo a rapid development in structure and function of their body and its organ systems.
It is known that the development of childhood obesity and metabolic health disorders may originate from a sub-optimal development of metabolic organs during early life. A high maternal pre-pregnancy overweight, prenatal tobacco exposure, Gestational Diabetes, maternal excess gestational weight gain, high infant birth weight, (preterm birth), and unbalanced and/or accelerated infant growth are all known to be associated with adverse metabolic development 1.
Early Nutrition and Body Composition Development
Rapid or unbalanced postnatal growth during the first year of life might cause increased body fat accumulation linked to unfavorable metabolic health effects in later life2. During the early postnatal period, nutrition plays an important role in supporting infant growth and development3. Breastfed infants have a different growth pattern and body composition development compared to formula-fed infants. After the first months of life, growth rates diverge markedly between breastfed and formula-fed infants leading to a lower weight in breastfed infants at 1 year. Differences in length gain are less pronounced and as a result, breastfed infants have a lower body mass index (BMI, weight/length2) than formula-fed infants at 1 year4. A cross-sectional meta-analysis revealed that also differences in body fat development exist, with lower fat mass, fat mass percentage and fat mass index in breastfed infants compared to formula fed infants at 1 year of age5. However, longitudinal studies describing detailed body composition development of infants in relation with infant nutrition are scarce.
Methodology and intervention
Sophia PLUTO study cohort (CCMO registration NL 39625.078.12)
In the Sophia PLUTO study cohort, longitudinal body fat development is studied in healthy, term born infants from birth until 2 years of age with several consecutive state-of-the-art methods. Infants are recruited from several hospitals in and near Rotterdam. The cohort is led by Professor Anita Hokken-Koelega from the Sophia Children’s Hospital, Erasmus Medical Center, Rotterdam, The Netherlands. The infants have regular outpatient clinic visits up to 2 years at which total body fat (Peapod and/or DXA) and visceral adiposity (Ultrasound) is recorded. Apart from providing reference values for body composition development, the interaction with growth, feeding types and maternal characteristics is investigated6.
To learn more about the Sophia Pluto Cohort click here (Erasmus MC website, in Dutch).
Sophia SATURN study (CCMO registration NL64048.078.18)
During early life, adequate nutritional intake is of key importance to support healthy growth and development of infants. Breastfeeding is the gold standard, but unfortunately not always possible. Substitutes should therefore aim to provide nutritional and functional properties and benefits as close as possible to those of human milk. Lipid droplets in infant formulas differ from those in human milk being smaller in size and lacking a phospholipid membrane. Based on the natural fat globule structure of human milk, an innovative infant formula concept Nuturis® was developed with large, phospholipid-coated lipid droplets more similar to those present in human milk7.
Studies supporting Nuturis®
This infant formula concept has shown to alter in vitro lipid digestion kinetics8 and the postprandial lipid response in adult men 9. In pre-clinical studies, Nuturis® has shown to prevent excessive fat accumulation and adverse metabolic outcomes in nutritional programming models10,11,12 as well as to improve specific cognitive behaviors compared to standard infant formula13. Hence, introducing large, phospholipid coated lipid droplets might bring the physiological properties of infant formula closer to that of human milk. In two clinical studies, Nuturis® was demonstrated to be well-tolerated, supporting adequate growth and to be safe for use in healthy term infants; Mercurius study (CCMO registration NL42715.072.12) and Venus study (clinical trial NCT01609634)14, 15.
For more information on Danone Nutricia Research’s work in OPtimal Growth please see our website.