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NCT00624689 Clinical Trial

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

Infant Clinical Trial

— TUMME  

Official title:
Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00624689
Other study ID # TUMME
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2008
Est. completion date November 2018

Study information
Verified date November 2020
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date November 2018
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Dept of clinical sciences, pediatrics, Umeå University Umeå

Sponsors (1)
Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Neurological development Wechsler Intelligence Scale for Children, 4th Ed (higher score - better outcome) 6.5 years
Primary Body composition Pletysmography (% body fat) 4 months
Secondary Neurological development Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome) 1 year
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