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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00624689
Acronym
TUMME
Enrollment
240
Registered
2008-02-27
Start date
2008-03-31
Completion date
2018-11-30
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant

Keywords

Body composition, Glucose tolerance, Intima-media thickness, Visual acuity, Neurological development

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.

Interventions

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

MFGM-enriched formula with reduced energy and protein content

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body composition4 monthsPletysmography (% body fat)

Secondary

MeasureTime frameDescription
Neurological development1 yearBayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome)

Other

MeasureTime frameDescription
Neurological development6.5 yearsWechsler Intelligence Scale for Children, 4th Ed (higher score - better outcome)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026