Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
NCT ID: NCT01627015
Last Updated: 2015-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-06-30
2014-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Modified infant follow-on formula
Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol
Modified infant follow-on formula
The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
Standard infant follow-on formula
Infants are fed a commercial follow-on formula for 4 weeks, according to protocol
Standard infant follow-on formula
Infants are fed a commercial follow-on formula
Interventions
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Modified infant follow-on formula
The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
Standard infant follow-on formula
Infants are fed a commercial follow-on formula
Eligibility Criteria
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Inclusion Criteria
* 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
* drug and/or alcohol abuses of mother
* chronic medication
* participation of the infant in another intervention study
* gestational diabetes of the mother
4 Months
6 Months
ALL
Yes
Sponsors
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Beneo GmbH
INDUSTRY
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Koletzko - Office
Prof. Berthold Koletzko
Principal Investigators
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Berthold Koletzko, Prof.
Role: STUDY_DIRECTOR
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
Berthold Koletzko, Prof.
Role: PRINCIPAL_INVESTIGATOR
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
Locations
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Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
Munich, , Germany
Countries
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References
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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.
Other Identifiers
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114-12
Identifier Type: -
Identifier Source: org_study_id
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