Breast FeedingNCT02033005
Newborn Feeding and Infant Phenotype
An observational study of Breast Feeding, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.
Who may be able to join
- Healthy baby
- Term baby
- Appropriate weight for gestational age (UK - WHO 2009 growth charts)
Who cannot join
- Infants of diabetic mothers
- Infants of smokers
- Infants fed non-commercial or non-cows milk based infant formulae
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
About this study
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.
- Conditions
- Breast Feeding
- Keywords
- Body Composition, Adipose Tissue, Intrahepatocellular Lipid, Infant, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Adipose Tissue Volume
Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.
Measured: Between birth and 6-12 weeks age
Secondary outcomes (2)
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
Measured: Between birth and 6-12 weeks age
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
Measured: Between birth and 6-12 weeks age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Neena Modi, MBBS, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033005
- Sponsor's protocol ID
- CRO1461
- Status last verified
- Oct 2022
- First submitted
- 9 Jan 2014
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24572562
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Feeding and Infant Phenotype
- ClinicalTrials.gov ID
- NCT02033005
- Acronym / sponsor ID
- CRO1461
- Conditions
- Breast Feeding
- Keywords
- Body Composition, Adipose Tissue, Intrahepatocellular Lipid, Infant, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.
Key inclusion criteria (3 listed)
- Healthy baby
- Term baby
- Appropriate weight for gestational age (UK - WHO 2009 growth charts)
Key exclusion criteria (3 listed)
- Infants of diabetic mothers
- Infants of smokers
- Infants fed non-commercial or non-cows milk based infant formulae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.
Time frame: Between birth and 6-12 weeks age
Change in Intrahepatocellular Lipid Compared to Breastfed Infants.
Time frame: Between birth and 6-12 weeks age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24572562Gale 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.
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Methyl Donor-Rich Diet in the Postpartum Period
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neena Modi, MBBS, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Adipose Tissue Volume (time frame: Between birth and 6-12 weeks age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.