The Movie Theater Study

Hyperinsulinemia Clinical Trial

Official title: The Movie Theater Study: Acute Cardiometabolic Effects of a Cinema-Style Meal

Status Recruiting

Clinical Trial Summary

Increasing attention has been paid to meals with unusual characteristics that are consumed on a semi-regular basis (e.g., "tailgating," pizza buffets). The purpose of this study is to describe the acute cardiometabolic effects of a cinema-style meal rich in refined sugar, total carbohydrate, and moderate in fat (i.e., soda, popcorn, candy).

Clinical Trial Description

Participants will complete two study visits in random order. For one visit, participants will consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles) in the morning while fasting (i.e., the "fasting trial"). For the other visit, participants will report fasting and then first consume a high-fat meal (two Jimmy Dean's breakfast sandwiches; the "fed trial"). After consuming the high-fat meal during the fed trial, participants will be allowed to leave for three hours. During this three-hour period, the investigators will ask participants to only consume water and remain sedentary. Upon return, participants will consume the same movie theater style meal (popcorn, soda, candy).

Regardless of fasting or fed trials, procedures for this study will be largely similar between the two visits. Participants will arrive having fasted for ~10 hours, avoided exercise and alcohol for > 24 hours, and avoided anti-inflammatory medications for > 72 hours. First, the investigators will perform a baseline vascular ultrasound using the flow-mediated dilation (FMD) technique on all participants. Upon completion of FMD, the investigators will perform a blood draw in one of two ways (depending on the trial). For the fasting trial, the investigators will insert an indwelling intravenous catheter (IV) to minimize needle sticks. After a baseline blood sample is collected, participants will consume the movie theater-style meal and remain in the lab for four hours. During this time, the investigators will collect blood samples at 0.5-, 1-, 2-, 3-, and 4-hours post meal to measure potential changes in metabolic and inflammatory markers and indicators of endotoxemia. The investigators will also measure FMD at 2- and 4-hours post movie theater-style meal. During the fed trial, the investigators will first perform a single venipuncture to obtain a blood sample in order to have a true baseline sample for the fed trial. When participants return from this three-hour break, the procedures for the fed trial will be identical to the fasting trial (IV inserted, moving theater meal consumed, serial blood draws and FMD completed at the same timepoints over a four-hour period). ;

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperglycemia, Postprandial
• Hyperinsulinemia
• Hyperinsulinism

• NCT number: NCT06444984
• Study type: Interventional
• Source: Ball State University
• Contact: Bryant Keirns, PhD
• Phone: 7652858356
• Email: bryant.keirns@bsu.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2024
• Completion date: March 2025