Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development
This trial is active, not recruiting.
|Treatment||modified formula (mfgm-enriched formula with reduced energy and protein content)|
|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.
|Endpoint classification||pharmacodynamics study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 4 months
time frame: 1 year
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
|Official title||Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development|
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