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

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Other: breast milk; Other: standard infant formula; Other: modified infant formula

• Registration Number: NCT01094080
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Primary Completion: 2011-09
• Study Completion: 2018-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breast milk	breast milk	infants are breast fed
standard infant formula	standard infant formula	infants are fed a commercial formula during the first 4 month of life, according to protocol
modified infant formula	modified infant formula	infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol

Primary Outcome Measures

Name	Time	Method
change of weight from day 30 to day 120	postnatal age 30 to 120 days

Secondary Outcome Measures

Name	Time	Method
anthropometry	postnatal day 30, day 60, day 90, day 120 days	including body length, head circumference and derived parameter e.g. weight (from primary outcome) for length
blood markers	postnatal day 30, day 60, day 90, day 120 days (120 only)
Follow-up	4 Years of age	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.
Follow-up at age 7 years with an interview regarding severe events and growth	7 years of age	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

Trial Locations

Locations (2)

Institute for Gynecology and Obstretition of Clinical Center; 🇷🇸 Belgrade, Serbia

Hauner Childrens Hospital, LudwigMaximilans Universität; 🇩🇪 Muenchen, Germany