Clincosm LogoSign in Get a demo

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

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Completed
CT.gov ID
NCT01627015
Collaborator
Beneo GmbH (Industry)
50
Enrollment
1
Location
2
Arms
22
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Modified infant follow-on formula
  • Other: Standard infant follow-on formula
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. metabolic response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Months to 6 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich Munich Germany 80337

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Koletzko - Office, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01627015
Other Study ID Numbers:
  • 114-12
First Posted:
Jun 25, 2012
Last Update Posted:
Mar 9, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Koletzko - Office, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
Fully formula fed

Study Results

No Results Posted as of Mar 9, 2015