Newborn Feeding and Infant Phenotype

Breast Feeding Clinical Trial

Official title:

Newborn Feeding and Infant Phenotype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033005
• Other study ID #: CRO1461
• Status: Completed
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

• Healthy baby

• Term baby

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

Exclusion Criteria:

• Infants of diabetic mothers

• Infants of smokers

• Infants fed non-commercial or non-cows milk based infant formulae

Related Conditions & MeSH terms

• Breast Feeding

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Adipose Tissue Volume	Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.	Between birth and 6-12 weeks age
Secondary	Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.	Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging	Between birth and 6-12 weeks age
Secondary	Change in Intrahepatocellular Lipid Compared to Breastfed Infants.	Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy	Between birth and 6-12 weeks age