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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Niklas Timby, Umeå University
ClinicalTrials.gov Identifier:
NCT00624689
First received: February 15, 2008
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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 Intervention
Infant, Newborn
Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Body composition [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological development [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2008
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624689

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

Additional Information:
No publications provided

Responsible Party: Niklas Timby, M.D, Researcher, Umeå University
ClinicalTrials.gov Identifier: NCT00624689     History of Changes
Other Study ID Numbers: TUMME
Study First Received: February 15, 2008
Last Updated: November 11, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014