Body Composition Clinical Trial
— Baby Fat PilotOfficial title:
Measurement of Body Fat in Infants
Verified date | December 2021 |
Source | Pennington Biomedical Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2, 2019 |
Est. primary completion date | December 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 28 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Pennington Biomedical Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole Body Fat Mass | Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry. | 1 day | |
Primary | Average Brown Adipose Tissue Volume at First Visit | 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%. | 1 day | |
Primary | Average Brown Adipose Tissue Volume at Second Visit | 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%. | 1 day | |
Secondary | Average Fat Signal Fraction of Brown Adipose Tissue at First Visit | 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. | 1 day | |
Secondary | Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit | 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. | 1 day | |
Secondary | Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit | 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. | 2 days within 10 days apart |
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