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

Obesity Clinical Trial

— OPBIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353464
• Other study ID #: 2306009984
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Drexel University
• Contact: Principal Investigator, PhD RD
• Phone: (267) 359 -6287
• Email: foodbrainstudies[@]drexel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grams of pizza consumed	Ad libitum during the pizza eating episode	3-15 minutes
Primary	Baseline medial prefrontal cortex oxygenated hemoglobin	Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex prior to pizza consumption	20 minutes
Primary	Baseline lateral prefrontal cortex oxygenated hemoglobin	Micromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex prior to pizza consumption	20 minutes
Primary	medial prefrontal cortex Oxygenated hemoglobin concentration	Micromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex during pizza consumption phase	3-15 minutes
Primary	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	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
Secondary	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
Secondary	Preload Oxygenated Hemoglobin Difference	The difference between the oxygenated hemoglobin concentrations obtained under the two different preloads	5 minutes