The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.
Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
249
Test formula with lower protein content than standard formula
Standard infant formula
UCL Institute of Child Health
London, United Kingdom
Infant weight gain
Rate of weight gain (g/d)
Time frame: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Body mass index (BMI)-for-age Z-score
Based on World Health Organization (WHO) growth standards
Time frame: Age 2 years (+/- 1 month)
Height-for-age Z-score
Based on WHO growth standards
Time frame: Age 2 years (+/- 1 month)
Adiposity
Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac)
Time frame: Age 2 years (+/- 1 month)
Fat mass
Deuterium dilution (assessed in subset)
Time frame: Age 2 years (+/- 1 month)
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