Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development (TUMME)
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|ClinicalTrials.gov Identifier: NCT00624689|
Recruitment Status : Unknown
Verified October 2016 by Niklas Timby, Umeå University.
Recruitment status was: Active, not recruiting
First Posted : February 27, 2008
Last Update Posted : October 31, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Infant||Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2018|
Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)
MFGM-enriched formula with reduced energy and protein content
No Intervention: 2
No Intervention: 3
- Body composition [ Time Frame: 4 months ]
- Neurological development [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624689
|Dept of clinical sciences, pediatrics, Umeå University|
|Umeå, Sweden, SE-90185|