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| Name | Class |
|---|---|
| Chelsea and Westminster NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Intrahepatocellular Lipid Compared to Breastfed Infants. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.
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| Name | Affiliation | Role |
|---|---|---|
| Neena Modi, MBBS, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital NHS Foundation Trust | London | SW10 9NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24572562 | Derived | 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. |
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Participants consisted of healthy, full term, appropriate weight-for-gestational age infants from 2 cohorts: recruited between November 1999 and October 2001 at the Hammersmith Hospital, and between March 2010 and May 2012 from the postnatal ward at Chelsea and Westminster Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breastfed Infants | >80% of feeds consisting of breast milk at both scanning points |
| FG001 | Mixed-fed Infants | 20%-80% of feeds consisting of breast milk. |
| FG002 | Formula-fed Infants | >80% of feeds consisting of formula milk at both scanning points |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breastfed Infants | >80% of feeds consisting of breast milk at both scanning points |
| BG001 | Mixed-fed Infants | 20%-80% of feeds consisting of breast milk. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Adipose Tissue Volume | Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging. | Reduced participant number for this analysis represents missing data for some infants at one scan point | Posted | Median | Inter-Quartile Range | Litres | Between birth and 6-12 weeks age |
|
2 years and 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breastfed Infants | >80% of feeds consisting of breast milk at both scanning points |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Chris Gale | Imperial College London | +44 (0) 2033153519 | christopher.gale@imperial.ac.uk |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Urine Stool Breast milk
Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy |
| Between birth and 6-12 weeks age |
| BG002 | Formula-fed Infants | >80% of feeds consisting of formula milk at both scanning points |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Length | Mean | Standard Deviation | m |
|
| Head circumference | Mean | Standard Deviation | cm |
|
| Total adipose tissue | Median | Inter-Quartile Range | l |
|
| Total adipose tissue mass % | Median | Inter-Quartile Range | Percentage of mass |
|
| Superficial subcutaneous abdominal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Superficial subcutaneous non-abdominal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Deep subcutaneous abdominal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Deep subcutaneous non-abdominal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Internal abdominal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Internal non-abdominal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Total subcutaneous adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Total internal adipose tissue | Median | Inter-Quartile Range | Litres |
|
| Intrahepatocellular lipid | Median | Inter-Quartile Range | Ratio of CH2 (methylene) to H2O (water) |
|
| Formula-fed Infants |
>80% of feeds consisting of formula milk at both scanning points |
|
|
| 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 | Reduced participant number for this analysis represents missing data for some infants at one scan point | Posted | Median | Inter-Quartile Range | no unit (ratio) | 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 | Reduced number of participants due to missing intrahepatocellular lipid data in some cases | Posted | Median | Inter-Quartile Range | ratio of CH2 to water | Between birth and 6-12 weeks age |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Mixed-fed Infants | 20%-80% of feeds consisting of breast milk. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Formula-fed Infants | >80% of feeds consisting of formula milk at both scanning points | 0 | 25 | 0 | 25 | 0 | 25 |
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