A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation (OPBIM)

April 2, 2024 updated by: Drexel University
This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

1) Abstract of the study A positive energy balance (greater intake than expenditure) can explain weight gain and, when protracted, leads to overweight and obesity. The major question addressed in this proposal is if the timing of activation of specific regions of the brain is predictive of excessive food intake. Functional near infra-red spectroscopy (fNIR), seldom used in human eating studies, provides data similar to functional magnetic resonance imaging (fMRI) but allows for measurement of brain activation during food consumption. The investigator's pilot fNIR data reveal that varying patterns of regional PFC activation are associated with "loss of control" over eating, and that only 60% of individuals respond to acute protein intake with a reduction in food intake. Using fNIR and an acute protein challenge, the investigator will assess the effect of family history of obesity in humans on the satiation response to protein and concomitant activation of the prefrontal cortex (PFC). It is hypothesized that activation of the human medial PFC before the lateral PFC will result in greater intake of palatable food in those subjects with a proneness to obesity, and that these subjects will be less sensitive to the satiety-inducing effects of a protein preload. These results should provide an innovative and useful method for assessing risk for developing obesity and usefulness of preventative interventions.

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.
Interventional

Enrollment (Estimated)

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.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • BMI 20-40
  • weight stable for at least 3 months
  • no parents with history of obesity in adulthood, or at least one parent with history of obesity in adulthood

Exclusion Criteria

  • no current diagnosis of psychiatric disorders
  • no current diagnosis of neurological disorders
  • no current diagnosis or history of anorexia nervosa
  • no current diagnosis or history of bulimia nervosa
  • no pregnancy within the last 9 months
  • not currently breastfeeding
  • no use of investigational medication in the past 6 months
  • no use of prescription anti-seizure medications.
  • no use of prescription antidepressant medications
  • no use of prescription antipsychotic medications

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Preloads
Delivery of two different preloads to all participants, each preload tested on a separate day/participant, prior to consumption of pizza
Other: Ensure and Water
Ensure, a liquid meal with 9 grams of protein in 8 ounces consumed 20 minutes before eating pizza; and water, 8 ounces consumed 20 minutes before eating pizza

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
Grams of pizza consumed
Time Frame: 3-15 minutes
Ad libitum during the pizza eating episode
3-15 minutes
Baseline medial prefrontal cortex oxygenated hemoglobin
Time Frame: 20 minutes
Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex prior to pizza consumption
20 minutes
Baseline lateral prefrontal cortex oxygenated hemoglobin
Time Frame: 20 minutes
Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex prior to pizza consumption
20 minutes
medial prefrontal cortex Oxygenated hemoglobin concentration
Time Frame: 3-15 minutes
Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex during pizza consumption phase
3-15 minutes
lateral prefrontal cortex Oxygenated hemoglobin concentration
Time Frame: 3-15 minutes
Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex during pizza consumption phase
3-15 minutes

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
medial prefrontal cortex Time to Peak Light Intensity
Time Frame: 3-15 minutes
The time in seconds that it takes for the oxygenated hemoglobin signal to reach peak in the medial prefrontal cortex during the ad libitum eating episode for each preload
3-15 minutes
lateral prefrontal cortex Time to Peak Light Intensity
Time Frame: 3-15 minutes
The time in seconds that it takes for the oxygenated hemoglobin signal to reach peak in the lateral prefrontal cortex during the ad libitum eating episode for each preload
3-15 minutes
Preload Oxygenated Hemoglobin Difference
Time Frame: 5 minutes
The difference between the oxygenated hemoglobin concentrations obtained under the two different preloads
5 minutes

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.
Drexel University

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.
October 4, 2023

Primary Completion (Estimated)

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.
September 1, 2025

Study Completion (Estimated)

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.
September 1, 2025

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).
February 15, 2024

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 2, 2024

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 9, 2024

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.
April 9, 2024

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.
April 2, 2024

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.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 2306009984

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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