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

This study has been completed.
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: March 6, 2015
Last verified: March 2015
  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.


Enrollment: 50
Study Start Date: June 2012
Study Completion Date: April 2014
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
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
  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: March 6, 2015
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 September 03, 2015