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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06353464
Acronym
OPBIM
Enrollment
80
Registered
2024-04-09
Start date
2023-10-04
Completion date
2025-09-30
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

OTHEREnsure 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

Sponsors

Drexel University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Participants consume two preloads one at each visit, but are not informed which preload is being consumed on which test visit.

Intervention model description

individuals consume two distinct preloads at separate sessions

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
lateral prefrontal cortex Oxygenated hemoglobin concentration3-15 minutesMicromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex during pizza consumption phase
Baseline medial prefrontal cortex oxygenated hemoglobin20 minutesMicromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex prior to pizza consumption
Baseline lateral prefrontal cortex oxygenated hemoglobin20 minutesMicromoles per millimeter of oxygenated hemoglobin of the lateral prefrontal cortex prior to pizza consumption
medial prefrontal cortex Oxygenated hemoglobin concentration3-15 minutesMicromoles per millimeter of oxygenated hemoglobin of the medial prefrontal cortex during pizza consumption phase
Grams of pizza consumed3-15 minutesAd libitum during the pizza eating episode

Secondary

MeasureTime frameDescription
lateral prefrontal cortex Time to Peak Light Intensity3-15 minutesThe 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
Preload Oxygenated Hemoglobin Difference5 minutesThe difference between the oxygenated hemoglobin concentrations obtained under the two different preloads
medial prefrontal cortex Time to Peak Light Intensity3-15 minutesThe 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

Countries

United States

Contacts

Primary ContactPrincipal Investigator, PhD RD
foodbrainstudies@drexel.edu(267) 359 -6287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026