Newborn Feeding and Infant Phenotype

Completed

• Conditions: Breast Feeding

• Registration Number: NCT02033005
• Lead Sponsor: Imperial College London

Brief Summary

Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism.

I will compare adipose tissue and liver fat deposition in healthy, full term breast and formula fed infants babies shortly after birth and around 12 weeks.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Results First Submitted: 2017-08-22
• Results First Submitted QC: 2019-02-26
• Results First Posted: 2019-06-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Healthy baby
• Term baby
• Appropriate weight for gestational age (UK - WHO 2009 growth charts)

Read More

Exclusion Criteria

• Infants of diabetic mothers
• Infants of smokers
• Infants fed non-commercial or non-cows milk based infant formulae

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Total Adipose Tissue Volume	Between birth and 6-12 weeks age	Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.

Secondary Outcome Measures

Name	Time	Method
Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.	Between birth and 6-12 weeks age	Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging
Change in Intrahepatocellular Lipid Compared to Breastfed Infants.	Between birth and 6-12 weeks age	Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy

Trial Locations

Locations (1)

Chelsea and Westminster Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom