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Newborn Feeding and Infant Phenotype

Newborn Feeding and Infant Phenotype

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02033005
Enrollment
124
Registered
2014-01-10
Start date
2010-03-31
Completion date
2012-07-31
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding

Keywords

Body Composition, Adipose Tissue, Intrahepatocellular Lipid, Infant, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy

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.

Interventions

None listed

Sponsors

Chelsea and Westminster NHS Foundation Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 4 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Total Adipose Tissue VolumeBetween birth and 6-12 weeks ageDifference in total adipose tissue volume, measured using whole body magnetic resonance imaging.

Secondary

MeasureTime frameDescription
Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.Between birth and 6-12 weeks ageChange in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging
Change in Intrahepatocellular Lipid Compared to Breastfed Infants.Between birth and 6-12 weeks ageChange in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy

Countries

United Kingdom

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Breastfed Infants
\>80% of feeds consisting of breast milk at both scanning points
36
Mixed-fed Infants
20%-80% of feeds consisting of breast milk.
9
Formula-fed Infants
\>80% of feeds consisting of formula milk at both scanning points
25
Total70

Baseline characteristics

CharacteristicBreastfed InfantsMixed-fed InfantsFormula-fed InfantsTotal
Age, Categorical
<=18 years
36 Participants9 Participants25 Participants70 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous13 Days2 Days16 Days13 Days
Deep subcutaneous abdominal adipose tissue0.015 Litres0.013 Litres0.019 Litres0.016 Litres
Deep subcutaneous non-abdominal adipose tissue0.012 Litres0.012 Litres0.013 Litres0.013 Litres
Head circumference36.5 cm
STANDARD_DEVIATION 1.4
35.0 cm
STANDARD_DEVIATION 1.7
36 cm
STANDARD_DEVIATION 1.6
36.1 cm
STANDARD_DEVIATION 1.6
Internal abdominal adipose tissue0.017 Litres0.022 Litres0.017 Litres0.017 Litres
Internal non-abdominal adipose tissue0.054 Litres0.061 Litres0.052 Litres0.054 Litres
Intrahepatocellular lipid0.662 Ratio of CH2 (methylene) to H2O (water)1.126 Ratio of CH2 (methylene) to H2O (water)1.197 Ratio of CH2 (methylene) to H2O (water)0.949 Ratio of CH2 (methylene) to H2O (water)
Length0.533 m
STANDARD_DEVIATION 0.023
0.510 m
STANDARD_DEVIATION 0.025
0.523 m
STANDARD_DEVIATION 0.025
0.527 m
STANDARD_DEVIATION 0.025
Region of Enrollment
United Kingdom
36 participants9 participants25 participants70 participants
Sex: Female, Male
Female
11 Participants4 Participants15 Participants30 Participants
Sex: Female, Male
Male
25 Participants5 Participants10 Participants40 Participants
Superficial subcutaneous abdominal adipose tissue0.098 Litres0.110 Litres0.103 Litres0.101 Litres
Superficial subcutaneous non-abdominal adipose tissue0.512 Litres0.572 Litres0.521 Litres0.512 Litres
Total adipose tissue0.710 l0.802 l0.722 l0.718 l
Total adipose tissue mass %17.5 Percentage of mass21.3 Percentage of mass18.3 Percentage of mass18.1 Percentage of mass
Total internal adipose tissue0.070 Litres0.084 Litres0.069 Litres0.070 Litres
Total subcutaneous adipose tissue0.633 Litres0.718 Litres0.654 Litres0.644 Litres
Weight3.647 kg
STANDARD_DEVIATION 0.421
3.332 kg
STANDARD_DEVIATION 0.478
3.622 kg
STANDARD_DEVIATION 0.595
3.598 kg
STANDARD_DEVIATION 0.5

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 90 / 25
other
Total, other adverse events
0 / 360 / 90 / 25
serious
Total, serious adverse events
0 / 360 / 90 / 25

Outcome results

Primary

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

Population: Reduced participant number for this analysis represents missing data for some infants at one scan point

ArmMeasureValue (MEDIAN)
BreastfedChange in Total Adipose Tissue Volume0.718 Litres
Mixed-fed InfantsChange in Total Adipose Tissue Volume0.901 Litres
Formula-fed InfantsChange in Total Adipose Tissue Volume0.775 Litres
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

Time frame: Between birth and 6-12 weeks age

Population: Reduced number of participants due to missing intrahepatocellular lipid data in some cases

ArmMeasureValue (MEDIAN)
BreastfedChange in Intrahepatocellular Lipid Compared to Breastfed Infants.1.192 ratio of CH2 to water
Mixed-fed InfantsChange in Intrahepatocellular Lipid Compared to Breastfed Infants.-0.054 ratio of CH2 to water
Formula-fed InfantsChange in Intrahepatocellular Lipid Compared to Breastfed Infants.1.095 ratio of CH2 to water
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

Time frame: Between birth and 6-12 weeks age

Population: Reduced participant number for this analysis represents missing data for some infants at one scan point

ArmMeasureValue (MEDIAN)
BreastfedChange in Regional Adipose Tissue Distribution Compared to Breastfed Infants.-0.07 no unit (ratio)
Mixed-fed InfantsChange in Regional Adipose Tissue Distribution Compared to Breastfed Infants.-0.06 no unit (ratio)
Formula-fed InfantsChange in Regional Adipose Tissue Distribution Compared to Breastfed Infants.-0.03 no unit (ratio)

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026