Toddler Milk Intervention Trial

Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial

To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life

This study is designed to investigate in a randomized double-blind parallel-group trial the growth and metabolic effects of different contributions of protein to total energy intakes in healthy children during the second year of life

Inclusion Criteria:

• Having obtained his/her parents' (or his/her legally accepted representative [LAR's] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
• Child was born full term (≥ 37 weeks of gestation)
• Age at enrollment: between 11.5 months and 13.5 months of age
• 2.5 kg ≤ birth weight ≤ 4.5 kg
• Born from a singleton pregnancy
• Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

• Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
• Cows' milk allergy
• Lactose intolerance
• Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
• Infant who is being breastfed at the time of enrollment
• Infant who does not usually drink 300ml of cow's and/or formula milk per day
• Institutionalized children
• Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures