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

NCT06353464 | Recruiting

• 1 other identifier: 2306009984
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• medial prefrontal cortex Time to Peak Light Intensity

  3-15 minutes

• lateral prefrontal cortex Time to Peak Light Intensity

  3-15 minutes

• Preload Oxygenated Hemoglobin Difference

  5 minutes

Study Arms (1)

Preloads

EXPERIMENTAL

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

Interventions

Ensure and Water 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

Preloads

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Principal Investigator, PhD RD

CONTACT

(267) 359 -6287; foodbrainstudies@drexel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants consume two preloads one at each visit, but are not informed which preload is being consumed on which test visit.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: individuals consume two distinct preloads at separate sessions

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: April 9, 2024
• Study Start: October 4, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)