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

Umeå University

Status: Completed

Conditions: Infant

Treatments: Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)

Study type: Interventional

Funder types: Other

Identifiers

NCT00624689

TUMME

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups

1

Experimental group

Description:

Modified formula

Treatment:

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

2

No Intervention group

Description:

Standard formula

3

No Intervention group

Description:

Breastfed