The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants

Study Overview
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Brief Summary
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In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.

Detailed Description
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In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.

Official Title
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A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants

Conditions
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Growth

Intervention / Treatment
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* Other: infant formula based on hydrolyzed protein
* Other: infant formula based on intact protein


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Full-term infants (born at gestational age =37 weeks). Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records Boys and girls Apparently healthy at birth and screening Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2) Age at enrolment: =28 days of age Exclusively formula fed for at least 5 days prior to inclusion Exclusively formula fed during the entire intervention period Parents agreeing to initiate complementary feeding after finalization of the study Being available for follow up until the age of approximately 3.5 months Written informed consent from parent(s) and/or legal guardian(s) aged =18 years Exclusion criteria: Gestational age <37 weeks Birth weight <2500 g or >4200 g Age at enrolment: >28 days Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders) Illness at screening/inclusion Incapability of parents to comply with the study protocol Illiterate parents (i.e. not able to read and write in local language) Participation in another clinical trial Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 28 Days

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test formula<br>hydrolysed protein-based infant formula | Other: infant formula based on hydrolyzed protein<br>* infant formula based on hydrolysed protein<br>|
| Active Comparator: control formula<br>standard intact protein-based formula | Other: infant formula based on intact protein<br>* infant formula based on intact protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain | weight gain in g/day | until 17 weeks of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight in g | until 17 weeks of age | 
| Length | length in cm | until 17 weeks of age | 
| head circumference | head circumference in cm | until 17 weeks of age | 
| BMI | BMI in kg/m2 | until 17 weeks of age | 
| WAZ | weight-for-age Z-score | until 17 weeks of age | 
| LAZ | length-for-age Z-score | until 17 weeks of age | 
| WHZ | weight-for-height Z-score | until 17 weeks of age | 
| BMI-for-age Z-score | BMI-for-age Z-score | until 17 weeks of age | 
| head circumference-for-age Z-score | head circumference-for-age Z-score | until 17 weeks of age |