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OpenTrials
Completed

NCT Number: NCT03490227

Measurement of Body Fat in Infants

Up to 10 infants will complete the study aimed to establish a technique for measuring whole body adiposity and brown adipose tissue in infant subjects using dual energy x-ray absorptiometry and magnetic resonance imaging, respectively.

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Key information

Conditions

Brown Adipose Tissue Body Composition

Age range

14 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy, full-term infant
  • aged 14-28 days at Visit 1

Exclusion criteria

  • born preterm (<37 weeks gestation)
  • implanted metal or electronic objects that render MRI unsafe
  • unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center

Treatment and study plan

Primary outcomes

  1. Whole Body Fat Mass

    Time frame: 1 day

    Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.

  2. Average Brown Adipose Tissue Volume at First Visit

    Time frame: 1 day

    Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%.

  3. Average Brown Adipose Tissue Volume at Second Visit

    Time frame: 1 day

    Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%.

Secondary outcomes

  1. Average Fat Signal Fraction of Brown Adipose Tissue at First Visit

    Time frame: 1 day

    Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue.

  2. Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit

    Time frame: 1 day

    Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue.

  3. Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit

    Time frame: 2 days within 10 days apart

    Reliability of average brown adipose tissue volume measurement between visits was determined using intraclass correlation coefficient. Paired average brown adipose tissue volume measurements were included in the intraclass correlation coefficient computation.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: Baby Fat Pilot

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2018
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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