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

September 1, 2020 updated by: Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

505

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenchen, Germany, D-80337
        • Hauner Childrens Hospital, LudwigMaximilans Universität
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Gynecology and Obstretition of Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard infant formula
infants are fed a commercial formula during the first 4 month of life, according to protocol
Other: standard infant formula
infants are fed a commercial formula
Experimental: 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
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
Other: breast milk
infants are breast fed
Other: breast milk
infants are breast fed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of weight from day 30 to day 120
Time Frame: postnatal age 30 to 120 days
postnatal age 30 to 120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometry
Time Frame: postnatal day 30, day 60, day 90, day 120 days
including body length, head circumference and derived parameter e.g. weight (from primary outcome) for length
postnatal day 30, day 60, day 90, day 120 days
blood markers
Time Frame: postnatal day 30, day 60, day 90, day 120 days (120 only)
postnatal day 30, day 60, day 90, day 120 days (120 only)
Follow-up
Time Frame: 4 Years of age
At 4 Years of Age, an Interview Regarding Severe Events and Growth Since Study End Will be Performed and Anthropometric Data (Weight, Length, Head Circumference and Body Composition Measured Via Skinfolds and BIA) Will be Collected.
4 Years of age
Follow-up at age 7 years with an interview regarding severe events and growth
Time Frame: 7 years of age
At 7 years of age we will perform anthropometric measurements (weight, height, head circumference and skinfolds) and bioimpedance measurement (from skinfolds and bioimpedance body composition will be estimated) additionally in an interview information on severe events (i.e. diseases) will be collected
7 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

HiPP GmbH & Co. Vertrieb KG

Investigators

  • Study Director: Berthold Koletzko, Prof., Hauner Children Hospital, Ludwig Maximilians Universität
  • Principal Investigator: Tatjana Nicolić Nicolić, Dr., Institute for Gynecology and Obstretition of Clinical Center Belgrade

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 502042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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