Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula

March 6, 2015 updated by: Koletzko - Office, Ludwig-Maximilians - University of Munich

In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.

After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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
      • Munich, Germany, 80337
        • Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

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

4 months to 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • generally healthy infants born
  • weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
  • age between 5 - 7th month of life at study entry
  • fully formula fed for at least 4 weeks before intervention start
  • parents/caregivers understand the German language and are able to fill out questionnaires
  • parents/caregivers agree to study participation and sign the informed consent form

Exclusion Criteria:

  • acute or chronic illness of infant or mother
  • drug and/or alcohol abuses of mother
  • chronic medication
  • participation of the infant in another intervention study
  • gestational diabetes of the mother

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified infant follow-on formula
Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol
Other: Modified infant follow-on formula
The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
Active Comparator: Standard infant follow-on formula
Infants are fed a commercial follow-on formula for 4 weeks, according to protocol
Other: Standard infant follow-on formula
Infants are fed a commercial follow-on formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metabolic response
Time Frame: After 4 week intervention period
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
After 4 week intervention period

Collaborators and Investigators

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

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Beneo GmbH

Investigators

  • Study Director: Berthold Koletzko, Prof., Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
  • Principal Investigator: Berthold Koletzko, Prof., Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

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

June 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 114-12

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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