The Movie Theater Study

NCT06444984 | Recruiting

• 1 other identifier: 2141491-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hyperglycemia, Postprandial; Hyperinsulinemia

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (2)

Fasting Meal Trial

EXPERIMENTAL

During the fasting meal trial, participants will report fasted and consume a movie theater style meal.

Other: Fasting Trial

Fed Meal Trial

EXPERIMENTAL

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

Interventions

Fasting Trial OTHER

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.

Fasting Meal Trial

Fed Trial OTHER

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).

Fed Meal Trial

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ball State University: lead

Study Sites (1)

Health Professions Building, Ball State University

Muncie, Indiana, 47306, United States

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Hyperinsulinism

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bryant Keirns

  Ball State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryant Keirns, PhD

CONTACT

7652858356; bryant.keirns@bsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: March 24, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)