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

This study is currently recruiting participants.
Verified September 2013 by Ludwig-Maximilians - University of Munich
Sponsor:
Collaborator:
BENEO GmbH
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01627015
First received: June 21, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Infant Nutrition
Other: Modified infant follow-on formula
Other: Standard infant follow-on formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • metabolic response [ Time Frame: After 4 week intervention period ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627015

Contacts
Contact: Manja Fleddermann 49 89 5160 ext 3486 Manja.Fleddermann@med.uni-muenchen.de
Contact: Hans Demmelmair, Dr. 49 89 5160 ext 3692 Hans.Demmelmair@med.uni-muenchen.de

Locations
Germany
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich Recruiting
Munich, Germany, 80337
Contact: Martina Scheer    49 89 5160 ext 2833    Martina.Scheer@med.uni-muenchen.de   
Contact: Hans Demmelmair, Dr.    49 89 5160 ext 3692    Hans.Demmelmair@med.uni-muenchen.de   
Principal Investigator: Berthold Koletzko, Prof.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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
  More Information

No publications provided

Responsible Party: Koletzko - Office, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01627015     History of Changes
Other Study ID Numbers: 114-12
Study First Received: June 21, 2012
Last Updated: September 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
Fully formula fed

ClinicalTrials.gov processed this record on April 16, 2014