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

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ClinicalTrials.gov Identifier: NCT01627015
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : March 9, 2015
Sponsor:
Collaborator:
Beneo GmbH
Information provided by (Responsible Party):
Koletzko - Office, Ludwig-Maximilians - University of Munich

June 21, 2012
June 25, 2012
March 9, 2015
June 2012
April 2014   (Final data collection date for primary outcome measure)
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.
metabolic response [ Time Frame: After 4 week intervention period ]
Primary hypothesis to be tested is: 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.
Complete list of historical versions of study NCT01627015 on ClinicalTrials.gov Archive Site
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Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Infant Nutrition
  • Other: Modified infant follow-on formula
    The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
  • Other: Standard infant follow-on formula
    Infants are fed a commercial follow-on formula
  • Experimental: Modified infant follow-on formula
    Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol
    Intervention: Other: Modified infant follow-on formula
  • Active Comparator: Standard infant follow-on formula
    Infants are fed a commercial follow-on formula for 4 weeks, according to protocol
    Intervention: Other: Standard infant follow-on formula
Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B. Effects of a Follow-On Formula Containing Isomaltulose (Palatinose™) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial. PLoS One. 2016 Mar 17;11(3):e0151614. doi: 10.1371/journal.pone.0151614. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Months to 6 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01627015
114-12
No
Not Provided
Not Provided
Koletzko - Office, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Beneo GmbH
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
Ludwig-Maximilians - University of Munich
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP