Measurement of Body Fat in Infants

Body Composition Clinical Trial

— Baby Fat Pilot  

Official title:

Measurement of Body Fat in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490227
• Other study ID #: PBRC 2017-050
• Status: Completed
• Start date: April 30, 2018
• Est. completion date: December 2, 2019

Study information

• Verified date: December 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Body Composition
• Brown Adipose Tissue

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

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