Measurement of Body Fat in Infants (Baby Fat Pilot)

December 2, 2021 updated by: Leanne Redman, Pennington Biomedical Research Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 10 healthy, full term infants aged 14 to 28 days old at enrollment with no contraindications to MRI will be recruited to Pennington Biomedical Research Center to participate in this study which includes two study visits to be completed within 1-10 days apart.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whole Body Fat Mass
Time Frame: 1 day
Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.
1 day
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%.
1 day
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%.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
2 days within 10 days apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pennington Biomedical Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBRC 2017-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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