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

NCT ID: NCT06353464

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2025-09-30

Brief 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Preloads

Delivery of two different preloads to all participants, each preload tested on a separate day/participant, prior to consumption of pizza

Group Type: EXPERIMENTAL

Ensure and Water

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Principal Investigator, PhD RD

Role: CONTACT

foodbrainstudies@drexel.edu

(267) 359 -6287

Facility Contacts

Principal Investigator, PhD RD

Role: primary

foodbrainstudies@drexel.edu

267-359-6287

Other Identifiers

2306009984

Identifier Type: -

Identifier Source: org_study_id