Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health

Infant Nutrition Clinical Trial

— BEMIM  

Official title:

Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094080
• Other study ID #: 502042
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: May 2018

Study information

• Verified date: September 2020
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: May 2018
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Other:
• standard infant formula
infants are fed a commercial formula
• modified infant formula
the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added
• breast milk
infants are breast fed

Locations

Country	Name	City	State
Germany	Hauner Childrens Hospital, LudwigMaximilans Universität	Muenchen
Serbia	Institute for Gynecology and Obstretition of Clinical Center	Belgrade

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	HiPP GmbH & Co. Vertrieb KG

Countries where clinical trial is conducted

Germany,  Serbia, 

References & Publications (2)

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. — View 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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of weight from day 30 to day 120		postnatal age 30 to 120 days
Secondary	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
Secondary	blood markers		postnatal day 30, day 60, day 90, day 120 days (120 only)
Secondary	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
Secondary	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