Toddler Milk Intervention Trial

Nestlé

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Young-child formula with low protein content

Dietary Supplement: Young-child formula with protein content similar to that of cow's milk

Study type

Interventional

Funder types

Industry

Identifiers

NCT02907502

13.29.INF

Details and patient eligibility

About

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

Full description

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

Enrollment

1,618 patients

Sex

All

Ages

11 to 13 months old

Volunteers

Accepts Healthy Volunteers

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