Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2018-05-31

Brief Summary

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In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.

Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.

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Detailed Description

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Conditions

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Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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standard infant formula

infants are fed a commercial formula during the first 4 month of life, according to protocol

Group Type ACTIVE_COMPARATOR

standard infant formula

Intervention Type OTHER

infants are fed a commercial formula

modified infant formula

infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol

Group Type EXPERIMENTAL

modified infant formula

Intervention Type OTHER

the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added

breast milk

infants are breast fed

Group Type OTHER

breast milk

Intervention Type OTHER

infants are breast fed

Interventions

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standard infant formula

infants are fed a commercial formula

Intervention Type OTHER

modified infant formula

the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added

Intervention Type OTHER

breast milk

infants are breast fed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy term newborn
* gestational age between 37 and 41 weeks
* birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
* fully bottle-fed (at the latest with 28 days of age) or fully breast fed
* written parental informed consent
* Serbian nationality

Exclusion Criteria

* malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
* intensive care during first 14 days of life
* participation in any other clinical study intervention
* twins, multiple birth
* neonatal infection
* medication and parenteral nutrition
* metabolic disorders
* birth-related complications
* severe disturbances of neonatal adaption

Minimum Eligible Age

3 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes