This trial is active, not recruiting.

Condition infant, newborn
Treatment modified formula (mfgm-enriched formula with reduced energy and protein content)
Sponsor Umeå University
Start date March 2008
End date March 2013
Trial size 240 participants
Trial identifier NCT00624689, TUMME


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Modified formula
modified formula (mfgm-enriched formula with reduced energy and protein content)
MFGM-enriched formula with reduced energy and protein content
(No Intervention)
Standard formula
(No Intervention)

Primary Outcomes

Body composition
time frame: 4 months

Secondary Outcomes

Neurological development
time frame: 1 year

Eligibility Criteria

Male or female participants up to 2 months old.

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

Additional Information

Official title Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Umeå University.