Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444984
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
The Movie Theater Study
Sponsor:
Ball State University
Organization:
Ball State University
Study Overview
Official Title:
The Movie Theater Study Acute Cardiometabolic Effects of a Cinema-Style Meal
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Increasing attention has been paid to meals with unusual characteristics that are consumed on a semi-regular basis eg 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 ie 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 217 oz of Skittles in the morning while fasting ie the fasting trial For the other visit participants will report fasting and then first consume a high-fat meal two Jimmy Deans 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 05- 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
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 05- 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None