NCT00624689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

5 years

First QC Date

February 15, 2008

Last Update Submit

November 13, 2020

Conditions

Infant

Keywords

Body compositionGlucose toleranceIntima-media thicknessVisual acuityNeurological development

Outcome Measures

Primary Outcomes (1)

  • Body composition

    Pletysmography (% body fat)

    4 months

Secondary Outcomes (1)

  • Neurological development

    1 year

Other Outcomes (1)

  • Neurological development

    6.5 years

Study Arms (3)

1

EXPERIMENTAL

Modified formula

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

2

NO INTERVENTION

Standard formula

3

NO INTERVENTION

Breastfed

Interventions

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

MFGM-enriched formula with reduced energy and protein content

1

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Term infants with birth weight 2500-4500 gr
  • Fed with breastmilk only or formula only before 2 months of age

You may not qualify if:

  • Chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of clinical sciences, pediatrics, Umeå University

Umeå, SE-90185, Sweden

Location

Related Publications (2)

  • Timby N, Hernell O, Vaarala O, Melin M, Lonnerdal B, Domellof M. Infections in infants fed formula supplemented with bovine milk fat globule membranes. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):384-9. doi: 10.1097/MPG.0000000000000624.

    PMID: 25714582DERIVED

  • Timby N, Domellof E, Hernell O, Lonnerdal B, Domellof M. Neurodevelopment, nutrition, and growth until 12 mo of age in infants fed a low-energy, low-protein formula supplemented with bovine milk fat globule membranes: a randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):860-8. doi: 10.3945/ajcn.113.064295. Epub 2014 Feb 5.

    PMID: 24500150DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Researcher

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2013

Study Completion

November 1, 2018

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

SE(1)