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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
1,618
Young-child formula with low protein content
Young-child formula with protein content similar to that of cow's milk
Dr Von Hauner Children's hospital
Munich, Germany
Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili.
Tarragona, Spain
BMI-for-age z-score
WHO-growth standard
Time frame: Age 24 months
BMI-for-age z-score
Time frame: Age 72 months
The percentage of overweight and obese children
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).
Time frame: Age 24 months
The percentage of overweight and obese children
Time frame: Age 72 months
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
Time frame: Age 12, 18, 24, 48 and 72 months
Child's development: Parental rating of child development with Ages & Stages Questionnaires®
Time frame: Age 24 and 48 months
Body composition: air displacement plethysmography
Time frame: at 24, 48 and 72 months of age
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)
Time frame: Age 12, 18, 24, 48 and 72 months
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DNA methylation pattern: Methylation status of specific DNA regions (e.g. CpG sites)
Time frame: Age 12, 24 and 72 months
Blood pressure
Time frame: Age 48 and 72 months
Dietary intake: 24-hour recall
Time frame: Age 12, 18, 24, 48 and 72 months
Metabolic and endocrine markers: Blood and Urine markers
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
Time frame: Age 12, 24 and 72 months