Recruiting

Observational Study

Sponsor:

Drexel University

Code:

NCT06353464

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Ensure and Water

Study Details

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

Study ID

NCT06353464

Start date

Oct 4, 2023

Status verified date

Apr, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Preloads

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

Primary outcome measure

  • Grams of pizza consumed [ Time Frame: 3-15 minutes ]
  • Baseline medial prefrontal cortex oxygenated hemoglobin [ Time Frame: 20 minutes ]
  • Baseline lateral prefrontal cortex oxygenated hemoglobin [ Time Frame: 20 minutes ]
  • medial prefrontal cortex Oxygenated hemoglobin concentration [ Time Frame: 3-15 minutes ]
  • lateral prefrontal cortex Oxygenated hemoglobin concentration [ Time Frame: 3-15 minutes ]

Central Contacts and Locations

Central contacts

Principal Investigator, PhD RD

(267) 359 -6287foodbrainstudies@drexel.edu

Locations

Drexel University

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator, PhD RD

267-359-6287foodbrainstudies@drexel.edu

More Information

Sponsor

Drexel University

Last update posted

Apr 9, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Drexel University on 2024-04-09.