Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial.

INTRODUCTION: Atopic dermatitis (AD) is a chronic, inflammatory skin condition significantly affecting quality of life. A small randomised trial showed an approximately one-third lower incidence of AD in goat milk formula-fed compared with cow milk formula-fed infants. However, due to limited statistical power, AD incidence difference was not found to be significant. This study aims to explore a potential risk reduction of AD by feeding a formula based on whole goat milk (as a source of protein and fat) compared with a formula based on cow milk proteins and vegetable oils. METHODS AND ANALYSIS: This two-arm (1:1 allocation), parallel, randomised, double-blind, controlled nutritional trial shall enrol up to 2296 healthy term-born infants until 3 months of age, if parents choose to start formula feeding. Ten study centres in Spain and Poland are participating. Randomised infants receive investigational infant and follow-on formulas either based on whole goat milk or on cow milk until the age of 12 months. The goat milk formula has a whey:casein ratio of 20:80 and about 50% of the lipids are milk fat from whole goat milk, whereas the cow milk formula, used as control, has a whey:casein ratio of 60:40 and 100% of the lipids are from vegetable oils. The energy and nutrient levels in both goat and cow milk formulas are the same. The primary endpoint is the cumulative incidence of AD until the age of 12 months diagnosed by study personnel based on the UK Working Party Diagnostic Criteria. The secondary endpoints include reported AD diagnosis, measures of AD, blood and stool markers, child growth, sleep, nutrition and quality of life. Participating children are followed until the age of 5 years. ETHICS AND DISSEMINATION: Ethical approval was obtained from the ethical committees of all participating institutions. TRIAL REGISTRATION NUMBER: NCT04599946.

Effect of milk protein content in Toddler formula on later BMI and obesity risk: protocol of the multicentre randomised controlled Toddler Milk Intervention (ToMI) trial.

INTRODUCTION: Reduction of milk protein content in infant formula provided during the first year of life has been shown to reduce early weight gain and obesity later in life. While rapid weight gain during the first 2 years of life is one of the strongest early predictors of obesity, the role of animal protein intake beyond the first year of life is unclear. The aim of this study is to examine the role of milk protein during the second year of life in healthy children on weight gain and obesity risk in preschool age. METHODS AND ANALYSIS: This randomised, double-blinded study enrolled 1618 children aged 11.5-13.5 months in Spain and Germany into two groups receiving isocaloric toddler milk with differing protein content during the second year of life. The experimental formula contains 1.5 g/100 kcal and the control formula 6.15 g/100 kcal protein and otherwise equal formula composition, except for modified fat content to achieve equal energy density. The primary endpoint is body mass index (BMI)-for-age z-score at the age of 24 months adjusted for BMI at 12 months of age. The children are followed until 6 years of age. ETHICS AND DISSEMINATION: Ethics approval was obtained from the ethical committees of the LMU University Hospital Munich, Germany (Nr. 555-15) and at Institut d'Investigació Sanitaria Pere Virgili, Reus, Spain (Ref. CEIm IISPV 013/2016). We aim at publishing results in peer-reviewed journals and sharing of results with study participants. TRIAL REGISTRATION NUMBER: NCT02907502.