Newborn Feeding and Infant Phenotype

October 24, 2022 updated by: Imperial College London

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Breastfed infants
>80% of feeds consisting of breast milk at both scanning points
Formula-fed infants
>80% of feeds consisting of formula milk at both scanning points
Mixed-fed infants
20%-80% of feeds consisting of breast milk.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.
Time Frame: 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
Between birth and 6-12 weeks age
Change in Intrahepatocellular Lipid Compared to Breastfed Infants.
Time Frame: Between birth and 6-12 weeks age
Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy
Between birth and 6-12 weeks age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Chelsea and Westminster NHS Foundation Trust

Investigators

  • Principal Investigator: Neena Modi, MBBS, MD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRO1461

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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