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| Name | Class |
|---|---|
| HiPP GmbH & Co. Vertrieb KG | INDUSTRY |
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In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.
Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard infant formula | Active Comparator | infants are fed a commercial formula during the first 4 month of life, according to protocol |
|
| modified infant formula | Experimental | infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol |
|
| breast milk | Other | infants are breast fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard infant formula | Other | infants are fed a commercial formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change of weight from day 30 to day 120 | postnatal age 30 to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| anthropometry | including body length, head circumference and derived parameter e.g. weight (from primary outcome) for length | postnatal day 30, day 60, day 90, day 120 days |
| blood markers | postnatal day 30, day 60, day 90, day 120 days (120 only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Koletzko, Prof. | Hauner Children Hospital, Ludwig Maximilians Universität | Study Director |
| Tatjana Nicolić Nicolić, Dr. | Institute for Gynecology and Obstretition of Clinical Center Belgrade | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hauner Childrens Hospital, LudwigMaximilans Universität | München | D-80337 | Germany | |||
| Institute for Gynecology and Obstretition of Clinical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24411489 | Result | Fleddermann M, Demmelmair H, Grote V, Nikolic T, Trisic B, Koletzko B. Infant formula composition affects energetic efficiency for growth: the BeMIM study, a randomized controlled trial. Clin Nutr. 2014 Aug;33(4):588-95. doi: 10.1016/j.clnu.2013.12.007. Epub 2013 Dec 30. | |
| 26621633 | Result | Fleddermann M, Demmelmair H, Grote V, Bidlingmaier M, Grimminger P, Bielohuby M, Koletzko B. Role of selected amino acids on plasma IGF-I concentration in infants. Eur J Nutr. 2017 Mar;56(2):613-620. doi: 10.1007/s00394-015-1105-9. Epub 2015 Nov 30. |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| modified infant formula |
| Other |
the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added |
|
| breast milk | Other | infants are breast fed |
|
| Follow-up | At 4 Years of Age, an Interview Regarding Severe Events and Growth Since Study End Will be Performed and Anthropometric Data (Weight, Length, Head Circumference and Body Composition Measured Via Skinfolds and BIA) Will be Collected. | 4 Years of age |
| Follow-up at age 7 years with an interview regarding severe events and growth | At 7 years of age we will perform anthropometric measurements (weight, height, head circumference and skinfolds) and bioimpedance measurement (from skinfolds and bioimpedance body composition will be estimated) additionally in an interview information on severe events (i.e. diseases) will be collected | 7 years of age |
| Belgrade |
| 11000 |
| Serbia |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |