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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Umeå University

Additional 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
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 September 22, 2014