Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
This study is currently recruiting participants.
Verified January 2013 by Ludwig-Maximilians - University of Munich
Sponsor:
Ludwig-Maximilians - University of Munich
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: January 2, 2013
Last verified: January 2013
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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: | January 2, 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 May 23, 2013