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

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: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Ensure and Water

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: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator, PhD RD; Phone Number: (267) 359 -6287; Email: foodbrainstudies@drexel.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Drexel University
      • Contact: Principal Investigator, PhD RD; Phone Number: 267-359-6287; Email: foodbrainstudies@drexel.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
medial prefrontal cortex Time to Peak Light Intensity	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	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	The difference between the oxygenated hemoglobin concentrations obtained under the two different preloads	5 minutes

Collaborators and Investigators

• Sponsor: Drexel University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID 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