Clinical trial NCT06444984: The Movie Theater Study
Official title: The Movie Theater Study: Acute Cardiometabolic Effects of a Cinema-Style Meal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperglycemia, Postprandial
Hyperinsulinemia
Lead sponsor: Ball State University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose
timeFrame: Through study completion, up to 1 year.
measure: Insulin
timeFrame: Through study completion, up to 1 year.
measure: Triglycerides
timeFrame: Through study completion, up to 1 year.
measure: HDL-C
timeFrame: Through study completion, up to 1 year.
measure: Lipopolysaccharide binding protein (LBP)
timeFrame: Through study completion, up to 1 year.
measure: soluble CD14 (sCD14)
timeFrame: Through study completion, up to 1 year.
measure: Interleukin (IL)-6
timeFrame: Through study completion, up to 1 year.
measure: Flow-mediated dilation
timeFrame: Through study completion, up to 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Muncie
country: United States
facility: Health Professions Building, Ball State University
state: Indiana
Study officials:
affiliation: Ball State University
name: Bryant Keirns
role: PRINCIPAL_INVESTIGATOR
References: