Newborn Feeding and Infant Phenotype
1 other identifier
observational
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedResults Posted
Study results publicly available
June 7, 2019
CompletedNovember 15, 2022
October 1, 2022
2.3 years
January 9, 2014
August 22, 2017
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.
Between birth and 6-12 weeks age
Change in Intrahepatocellular Lipid Compared to Breastfed Infants.
Between birth and 6-12 weeks age
Study Arms (3)
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.
Eligibility Criteria
Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.
You may qualify if:
- Healthy baby
- Term baby
- Appropriate weight for gestational age (UK - WHO 2009 growth charts)
You may not qualify if:
- Infants of diabetic mothers
- Infants of smokers
- Infants fed non-commercial or non-cows milk based infant formulae
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH, United Kingdom
Related Publications (1)
Gale C, Thomas EL, Jeffries S, Durighel G, Logan KM, Parkinson JR, Uthaya S, Santhakumaran S, Bell JD, Modi N. Adiposity and hepatic lipid in healthy full-term, breastfed, and formula-fed human infants: a prospective short-term longitudinal cohort study. Am J Clin Nutr. 2014 May;99(5):1034-40. doi: 10.3945/ajcn.113.080200. Epub 2014 Feb 26.
PMID: 24572562DERIVED
Biospecimen
Urine Stool Breast milk
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Chris Gale
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Neena Modi, MBBS, MD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 10, 2014
Study Start
March 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 15, 2022
Results First Posted
June 7, 2019
Record last verified: 2022-10