The Movie Theater Study

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hyperinsulinemia; Hyperglycemia, Postprandial
• Intervention / Treatment: Other: Fasting Trial; Other: Fed Trial

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryant Keirns, PhD; Phone Number: 7652858356; Email: bryant.keirns@bsu.edu

Study Locations

• United States
  • Indiana
    • Muncie, Indiana, United States, 47306
      • Recruiting
      • Health Professions Building, Ball State University
      • Contact: Bryant Keirns, PhD; Phone Number: 765-285-8356; Email: bryant.keirns@bsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-45 years old
• Not pregnant or expecting to become pregnant (females only)
• Not postmenopausal (females only).
• Not been diagnosed with a cardiometabolic conditions (e.g., heart disease, type 2 diabetes)
• Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
• Does not regularly take anti-inflammatory drugs (more than 2x week) or able to temporarily suspend use of anti-inflammatory drugs.
• Does not use glucose-lowering drugs (e.g., metformin)
• Does not use lipid-lowering drugs (e.g., statins)
• Does not use tobacco products or any illicit drugs.
• Does not have a pacemaker.

Exclusion Criteria:

• Not 18-45 years old
• Pregnant or expecting to become pregnant (females only)
• Postmenopausal (females only).
• Been diagnosed with a cardiometabolic conditions (e.g., heart disease, type 2 diabetes)
• Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
• Regularly take anti-inflammatory drugs (more than 2x week) or unable to temporarily suspend use of anti-inflammatory drugs.
• Use glucose-lowering drugs (e.g., metformin)
• Use lipid-lowering drugs (e.g., statins)
• Use tobacco products or any illicit drugs.
• Has a pacemaker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting Meal Trial; During the fasting meal trial, participants will report fasted and consume a movie theater style meal.	Other: Fasting Trial; Participants will report fasted and consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles) in the morning.
Experimental: Fed Meal Trial; During the fed meal trial, participants will report fasted and first consume a high-fat breakfast. Participants will then be asked to consume a movie theater style meal three hours later.	Other: Fed Trial; Participants will report fasted and first consume a high-fat meal (Jimmy Deans) in the morning. After a three-hour break, participants will consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	The investigators will measure glucose at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.	Through study completion, up to 1 year.
Insulin	The investigators will measure serum insulin at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.	Through study completion, up to 1 year.
Triglycerides	The investigators will measure triglycerides at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.	Through study completion, up to 1 year.
HDL-C	The investigators will measure HDL-C at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.	Through study completion, up to 1 year.
Lipopolysaccharide binding protein (LBP)	The investigators will measure serum LBP at baseline and 0.5-, 1-, 2-, 3-, and 4-hours. after each meal trial.	Through study completion, up to 1 year.
soluble CD14 (sCD14)	The investigators will measure serum sCD14 at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.	Through study completion, up to 1 year.
Interleukin (IL)-6	The investigators will measure serum IL-6 at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.	Through study completion, up to 1 year.
Flow-mediated dilation	The investigators will measure FMD at baseline, 2-hours, and 4-hours after each meal trial.	Through study completion, up to 1 year.

Collaborators and Investigators

• Sponsor: Ball State University
• Investigators: Principal Investigator: Bryant Keirns, Ball State University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Hyperinsulinism
• Other Study ID Numbers: 2141491-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No