Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial

Conditions
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Infant Formula, Growth

Intervention / Treatment
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* Other: Modified infant formula
* Other: Standard infant formula


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Weeks
Maximum Age: 15 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double-blind with nonrandomized breast-fed reference group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Modified infant formula given from 3 to 12 months of age, as per standard requirement. | Other: Modified infant formula<br>* Test formula with lower protein content than standard formula<br>|
| Active Comparator: Control Group<br>Standard infant formula given from 3 to 12 months of age, as per standard requirement. | Other: Standard infant formula<br>* Standard infant formula<br>|
| No Intervention: Breast-fed Reference Group<br>Non-randomized infants who are predominantly breast-fed at time of enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant weight gain | Rate of weight gain (g/d) | Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI)-for-age Z-score | Based on World Health Organization (WHO) growth standards | Age 2 years (+/- 1 month) | 
| Height-for-age Z-score | Based on WHO growth standards | Age 2 years (+/- 1 month) | 
| Adiposity | Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac) | Age 2 years (+/- 1 month) | 
| Fat mass | Deuterium dilution (assessed in subset) | Age 2 years (+/- 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein requirements, Adiposity, Body composition, Cardiovascular health