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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Infant Nutrition

Treatments: Other: modified infant formula; Other: breast milk; Other: standard infant formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01094080

502042

Details and patient eligibility

About

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.

Enrollment: 505 patients

Sex: All

Ages: 3 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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505 participants in 3 patient groups

standard infant formula

Active Comparator group

Description:

infants are fed a commercial formula during the first 4 month of life, according to protocol

Treatment:

Other: standard infant formula

modified infant formula

Experimental group

Description:

infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol

Treatment:

Other: modified infant formula

breast milk

Other group

Description:

infants are breast fed

Treatment:

Other: breast milk