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

Umeå University240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

240

Conditions

Infant

Interventions

Modified formula (MFGM-enriched formula with reduced energy and protein content)DIETARY_SUPPLEMENT

MFGM-enriched formula with reduced energy and protein content

Eligibility

Sex: ALLMax age: 2 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dept of clinical sciences, pediatrics, Umeå University

Umeå, Sweden

Outcomes

Primary Outcomes

Body composition

Pletysmography (% body fat)

Time frame: 4 months

Secondary Outcomes

Neurological development

Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome)

Time frame: 1 year

Data from ClinicalTrials.gov

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