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| Name | Class |
|---|---|
| Beneo GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified infant follow-on formula | Experimental | Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol |
|
| Standard infant follow-on formula | Active Comparator | Infants are fed a commercial follow-on formula for 4 weeks, according to protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified infant follow-on formula | Other | The modified infant follow-on formula has a different carbohydrate pattern than the standard formula |
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| Measure | Description | Time Frame |
|---|---|---|
| metabolic response | 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. | After 4 week intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Koletzko, Prof. | Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich | Study Director |
| Berthold Koletzko, Prof. | Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich | Munich | 80337 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26987056 | Derived | 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. |
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| Standard infant follow-on formula | Other | Infants are fed a commercial follow-on formula |
|