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OpenTrials
Completed

NCT Number: NCT00624689

Effects of Milk Fat Globule Membrane (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.

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Key information

Conditions

Infant

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of clinical sciences, pediatrics, Umeå University

Umeå, SE-90185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified formula (MFGM-enriched formula with reduced energy and protein content)

Dietary Supplement

MFGM-enriched formula with reduced energy and protein content

Primary outcomes

  1. Body composition

    Time frame: 4 months

    Pletysmography (% body fat)

Secondary outcomes

  1. Neurological development

    Time frame: 1 year

    Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome)

Other outcomes

  1. Neurological development

    Time frame: 6.5 years

    Wechsler Intelligence Scale for Children, 4th Ed (higher score - better outcome)

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Acronym: TUMME

Important dates

Study start
2008
Primary completion
2013
Study completion
2018
First posted
Feb 27, 2008
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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