Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development

Not Applicable

Completed

• Conditions: Infant
• Interventions: Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)

• Registration Number: NCT00624689
• Lead Sponsor: Umeå University

Brief Summary

Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.

The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-27
• Study Start: 2008-03
• Primary Completion: 2013-03
• Study Completion: 2018-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Term infants with birth weight 2500-4500 gr
• Fed with breastmilk only or formula only before 2 months of age

Exclusion Criteria

• Chronic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Modified formula (MFGM-enriched formula with reduced energy and protein content)	Modified formula

Primary Outcome Measures

Name	Time	Method
Body composition	4 months	Pletysmography (% body fat)

Secondary Outcome Measures

Name	Time	Method
Neurological development	1 year	Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome)

Trial Locations

Locations (1)

Dept of clinical sciences, pediatrics, Umeå University; 🇸🇪 Umeå, Sweden