Clinical trial NCT02907502: Toddler Milk Intervention Trial
Official title: Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 1618
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: BMI-for-age z-score
timeFrame: Age 24 months
Secondary outcomes:
measure: BMI-for-age z-score
timeFrame: Age 72 months
measure: The percentage of overweight and obese children
timeFrame: Age 24 months
measure: The percentage of overweight and obese children
timeFrame: Age 72 months
measure: Growth parameters: Anthropometry: Weight, Length, Heel knee length, Mid-arm circumference, Waist circumference, Hip circumference (only 48 months and 72 months), Head circumference, Triceps skinfold, Subscapular skinfold
timeFrame: Age 12, 18, 24, 48 and 72 months
measure: Child's development: Parental rating of child development with Ages & Stages Questionnaires®
timeFrame: Age 24 and 48 months
measure: Body composition: air displacement plethysmography
timeFrame: at 24, 48 and 72 months of age
measure: Metabolomic profile: Plasma and urine metabolic indicators of energy and protein metabolism (metabolomics with a focus on carnitines, amino acid catabolism, ketone bodies, Krebs cycle, and bacterial utilization of protein and carbohydrates)
timeFrame: Age 12, 18, 24, 48 and 72 months
measure: DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites)
timeFrame: Age 12, 24 and 72 months
measure: Blood pressure
timeFrame: Age 48 and 72 months
measure: Dietary intake: 24-hour recall
timeFrame: Age 12, 18, 24, 48 and 72 months
measure: Metabolic and endocrine markers: Blood and Urine markers
timeFrame: Age 12, 24 and 72 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dr Von Hauner Children's hospital
city: Tarragona
country: Spain
facility: Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili.
Study officials:
References:
citation: Grote V, Jaeger V, Escribano J, Zaragoza M, Gispert M, Grathwohl D, Koletzko B. 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. BMJ Open. 2021 Dec 7;11(12):e048290. doi: 10.1136/bmjopen-2020-048290.