An observational study in Breast Feeding, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged Up to 4 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Imperial College London · Observational
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.
Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.
Exclusion Criteria:
\>80% of feeds consisting of breast milk at both scanning points
\>80% of feeds consisting of formula milk at both scanning points
20%-80% of feeds consisting of breast milk.
Change in Total Adipose Tissue Volume
Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.
Time frame: Between birth and 6-12 weeks age
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
Time frame: 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
Time frame: Between birth and 6-12 weeks age
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.
| Milestone | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants |
|---|---|---|---|
| Started | 80 | 9 | 35 |
| Completed | 36 | 9 | 25 |
| Not completed | 44 | 0 | 10 |
Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.
| Litres | Breastfed | Mixed-fed Infants | Formula-fed Infants |
|---|---|---|---|
| Change in Total Adipose Tissue Volume | 0.718 (0.508 to 0.938) | 0.901 (0.452 to 1.053) | 0.775 (0.532 to 0.971) |
Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging
| no unit (ratio) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants |
|---|---|---|---|
| Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants. | -0.07 (-0.09 to -0.02) | -0.06 (-0.08 to -0.02) | -0.03 (-0.07 to 0.01) |
Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy
| ratio of CH2 to water | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants |
|---|---|---|---|
| Change in Intrahepatocellular Lipid Compared to Breastfed Infants. | 1.192 (0.226 to 1.967) | -0.054 (-.672 to 1.837) | 1.095 (-0.280 to 1.746) |
Collected over 2 years and 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breastfed Infants | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Mixed-fed Infants | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Formula-fed Infants | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| <=18 years | 36 | 9 | 25 | 70 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Days) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| Median | 13 (9 to 18) | 2 (1 to 10) | 16 (9 to 20) | 13 (9 to 17) |
| Sex: Female, Male(Participants) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| Female | 11 | 4 | 15 | 30 |
| Male | 25 | 5 | 10 | 40 |
| Region of Enrollment(participants) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| United Kingdom | 36 | 9 | 25 | 70 |
| Weight(kg) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| Mean | 3.647 ± 0.421 | 3.332 ± 0.478 | 3.622 ± 0.595 | 3.598 ± 0.500 |
| Length(m) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| Mean | 0.533 ± 0.023 | 0.510 ± 0.025 | 0.523 ± 0.025 | 0.527 ± 0.025 |
| Head circumference(cm) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| Mean | 36.5 ± 1.4 | 35.0 ± 1.7 | 36 ± 1.6 | 36.1 ± 1.6 |
| Total adipose tissue(l) | Breastfed Infants | Mixed-fed Infants | Formula-fed Infants | Total |
|---|---|---|---|---|
| Median | 0.710 (0.632 to 0.899) | 0.802 (0.620 to 0.949) | 0.722 (0.613 to 0.913) | 0.718 (0.621 to 0.921) |
10 further baseline measures are reported on the registry.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Imperial College London