Infant Formula, Growth
Conditions
Keywords
Protein requirements, Adiposity, Body composition, Cardiovascular health
Brief summary
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.
Detailed description
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.
Interventions
Test formula with lower protein content than standard formula
Standard infant formula
Sponsors
University College, London
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, randomized, double-blind with nonrandomized breast-fed reference group
Eligibility
Sex/Gender
ALL
Age
13 Weeks to 15 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy term infant * Infant is aged 14 weeks (+/- 1 week) * Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks
Exclusion criteria
* Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development * Infant born with congenital disease or malformation affecting growth and/or development * Food allergy to any trial products (e.g. milk, soy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant weight gain | Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks) | Rate of weight gain (g/d) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | Age 2 years (+/- 1 month) | Deuterium dilution (assessed in subset) |
| Body mass index (BMI)-for-age Z-score | Age 2 years (+/- 1 month) | Based on World Health Organization (WHO) growth standards |
| Height-for-age Z-score | Age 2 years (+/- 1 month) | Based on WHO growth standards |
| Adiposity | Age 2 years (+/- 1 month) | Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Head circumference | Ages 4, 5, 6, 12 and 24 months | Head circumference (cm) |
| Body mass index | Ages 6, 12 and 24 months | Weight and length or height will be combined to report BMI in kg/m\^2 |
| Weight-for-age Z-score | Ages 14 weeks and 4, 5, 6, 12 and 24 months | Based on WHO growth standards |
| Weight-for-length Z-score | Ages 14 weeks and 4, 5, 6, 12 and 24 months | Based on WHO growth standards |
| Height-for-age Z-score | Ages 14 weeks and 4, 5, 6, and 12 months | Based on WHO growth standards |
| Blood pressure | At age 12 and 24 months | Systolic and diastolic blood pressure (in a subset) |
| Adverse events | Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months | Safety |
| Feeding intake | Ages 14 weeks and 4, 5, 6, and 12 months | Infant feeding questionnaire |
| Feeding tolerance | Ages 14 weeks and 4, 5, 6, and 12 months | GI symptom and stool pattern questionnaire |
| Metabolic markers of cardiovascular health | Ages 6 and 12 months | Blood sample (in a subset) |
| BMI-for-age Z-score | Ages 14 weeks and 4, 5, 6, and 12 months | Based on WHO growth standards |
| Appetite and feeding / eating behavior | Ages 14 weeks and 4, 5, 6, and 24 months | Baby and Children's Eating Behavior Questionnaire |
| Infant weight gain | Between 6 and 12 months | Rate of weight gain (g/d) |
| Weight | Ages 4, 5, 6, 12 and 24 months | Body weight (kg) |
| Length or height | Ages 4, 5, 6, 12 and 24 months | Length or height (cm) |
Countries
United Kingdom
Outcome results
None listed