BabyGrowth: Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group Modified infant formula given from 3 to 12 months of age, as per standard requirement. |
Other: Modified infant formula
Test formula with lower protein content than standard formula
|
| Active Comparator: Control Group Standard infant formula given from 3 to 12 months of age, as per standard requirement. |
Other: Standard infant formula
Standard infant formula
|
| No Intervention: Breast-fed Reference Group Non-randomized infants who are predominantly breast-fed at time of enrollment. |
Outcome Measures
Primary Outcome Measures
- Infant weight gain [Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)]
Rate of weight gain (g/d)
Secondary Outcome Measures
- 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)
- Fat mass [Age 2 years (+/- 1 month)]
Deuterium dilution (assessed in subset)
Other Outcome Measures
- 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)
- 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
- BMI-for-age Z-score [Ages 14 weeks and 4, 5, 6, and 12 months]
Based on WHO growth standards
- 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)
- Blood pressure [At age 12 and 24 months]
Systolic and diastolic blood pressure (in a subset)
- Appetite and feeding / eating behavior [Ages 14 weeks and 4, 5, 6, and 24 months]
Baby and Children's Eating Behavior Questionnaire
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCL Institute of Child Health | London | United Kingdom | WC1N 1EH |
Sponsors and Collaborators
- Nestlé
- University College, London
Investigators
- Principal Investigator: Atul Singhal, MD, Childhood Nutrition Research Centre, University College London, Institute of Child Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15.09.INF