Healthy
Conditions
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
Interventions
DIETARY_SUPPLEMENTYoung-child formula with low protein content
Young-child formula with low protein content
DIETARY_SUPPLEMENTYoung-child formula with protein content similar to that of cow's milk
Young-child formula with protein content similar to that of cow's milk
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Months to 13 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI-for-age z-score | Age 24 months | WHO-growth standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of overweight and obese children | Age 24 months | CDC definition: Overweight above 85th to less than the 95th percentile and obese 95th percentile or greater and analyzed by the method of Peacock (Dichotomising continuous data while retaining statistical power using a distributional approach, Statistics in medicine, 2012). |
| 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 | Age 12, 18, 24, 48 and 72 months | — |
| Child's development: Parental rating of child development with Ages & Stages Questionnaires® | Age 24 and 48 months | — |
| Body composition: air displacement plethysmography | at 24, 48 and 72 months of age | — |
| BMI-for-age z-score | Age 72 months | — |
| DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites) | Age 12, 24 and 72 months | — |
| Blood pressure | Age 48 and 72 months | — |
| Dietary intake: 24-hour recall | Age 12, 18, 24, 48 and 72 months | — |
| Metabolic and endocrine markers: Blood and Urine markers | Age 12, 24 and 72 months | Blood: Complete blood count, Glucose, Creatinine, Ferritin (measured only at 24 months), 25-OH vitamin D (measured only at 24 months), Triglycerides, Total cholesterol, HDL- and LDL-cholesterol, Insulin, FGF-21, IGF-1, IGF-BP2, IGF-BP3, Leptin, Adiponectin, Ghrelin, Amino Acids, Serum albumin, Urea, C-reactive protein, Osteocalcin / Urine: Calcium, C-peptide, Creatinine, Urea nitrogen |
| 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) | Age 12, 18, 24, 48 and 72 months | — |
Countries
Germany, Spain
Outcome results
None listed