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

November 13, 2020 updated by: Niklas Timby, Umeå University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, SE-90185
        • Dept of clinical sciences, pediatrics, Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 4 months
Pletysmography (% body fat)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological development
Time Frame: 1 year
Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome)
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological development
Time Frame: 6.5 years
Wechsler Intelligence Scale for Children, 4th Ed (higher score - better outcome)
6.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TUMME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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