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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 : Active, not recruiting
First Posted : February 27, 2008
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Niklas Timby, Umeå University

Brief 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.


Condition or disease Intervention/treatment
Infant Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Primary Completion Date : March 2013
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: 1
Modified formula
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
Standard formula
No Intervention: 3
Breastfed



Primary Outcome Measures :
  1. Body composition [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Neurological development [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Sweden
Dept of clinical sciences, pediatrics, Umeå University
Umeå, Sweden, SE-90185
Sponsors and Collaborators
Umeå University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Niklas Timby, M.D, Researcher, Umeå University
ClinicalTrials.gov Identifier: NCT00624689     History of Changes
Other Study ID Numbers: TUMME
First Posted: February 27, 2008    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Niklas Timby, Umeå University:
Body composition
Glucose tolerance
Intima-media thickness
Visual acuity
Neurological development