Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development
NCT ID: NCT00624689
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2008-03-31
2018-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Modified formula
Modified formula (MFGM-enriched formula with reduced energy and protein content)
MFGM-enriched formula with reduced energy and protein content
2
Standard formula
No interventions assigned to this group
3
Breastfed
No interventions assigned to this group
Interventions
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Modified formula (MFGM-enriched formula with reduced energy and protein content)
MFGM-enriched formula with reduced energy and protein content
Eligibility Criteria
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Inclusion Criteria
* Fed with breastmilk only or formula only before 2 months of age
Exclusion Criteria
2 Months
ALL
Yes
Sponsors
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Umeå University
OTHER
Responsible Party
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Niklas Timby
M.D, Researcher
Locations
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Dept of clinical sciences, pediatrics, Umeå University
Umeå, , Sweden
Countries
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References
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Timby N, Hernell O, Vaarala O, Melin M, Lonnerdal B, Domellof M. Infections in infants fed formula supplemented with bovine milk fat globule membranes. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):384-9. doi: 10.1097/MPG.0000000000000624.
Timby N, Domellof E, Hernell O, Lonnerdal B, Domellof M. Neurodevelopment, nutrition, and growth until 12 mo of age in infants fed a low-energy, low-protein formula supplemented with bovine milk fat globule membranes: a randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):860-8. doi: 10.3945/ajcn.113.064295. Epub 2014 Feb 5.
Other Identifiers
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TUMME
Identifier Type: -
Identifier Source: org_study_id