Clinical trial NCT01094080: Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
Official title: Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: fully formula fed
fully breast fed
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: HiPP GmbH & Co. Vertrieb KG
First posted: 2010-03-26
Enrollment: 505
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* healthy term newborn
* gestational age between 37 and 41 weeks
* birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
* fully bottle-fed (at the latest with 28 days of age) or fully breast fed
* written parental informed consent
* Serbian nationality

Exclusion Criteria:

* malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
* intensive care during first 14 days of life
* participation in any other clinical study intervention
* twins, multiple birth
* neonatal infection
* medication and parenteral nutrition
* metabolic disorders
* birth-related complications
* severe disturbances of neonatal adaption

Primary outcomes:
measure: change of weight from day 30 to day 120
timeFrame: postnatal age 30 to 120 days
Secondary outcomes:
measure: anthropometry
timeFrame: postnatal day 30, day 60, day 90, day 120 days
measure: blood markers
timeFrame: postnatal day 30, day 60, day 90, day 120 days (120 only)
measure: Follow-up
timeFrame: 4 Years of age
measure: Follow-up at age 7 years with an interview regarding severe events and growth
timeFrame: 7 years of age
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Hauner Childrens Hospital, LudwigMaximilans Universität
city: Belgrade
country: Serbia
facility: Institute for Gynecology and Obstretition of Clinical Center
Study officials:
affiliation: Hauner Children Hospital, Ludwig Maximilians Universität
name: Berthold Koletzko, Prof.
role: STUDY_DIRECTOR
affiliation: Institute for Gynecology and Obstretition of Clinical Center Belgrade
name: Tatjana Nicolić Nicolić, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.