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临床试验/NCT06444984
NCT06444984招募中不适用

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

Ball State University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Insulin

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Insulin

时间窗: Through study completion, up to 1 year.

The investigators will measure serum insulin at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.

soluble CD14 (sCD14)

时间窗: Through study completion, up to 1 year.

The investigators will measure serum sCD14 at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.

Triglycerides

时间窗: Through study completion, up to 1 year.

The investigators will measure triglycerides at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.

Interleukin (IL)-6

时间窗: Through study completion, up to 1 year.

The investigators will measure serum IL-6 at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.

Glucose

时间窗: Through study completion, up to 1 year.

The investigators will measure glucose at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.

Lipopolysaccharide binding protein (LBP)

时间窗: Through study completion, up to 1 year.

The investigators will measure serum LBP at baseline and 0.5-, 1-, 2-, 3-, and 4-hours. after each meal trial.

Flow-mediated dilation

时间窗: Through study completion, up to 1 year.

The investigators will measure FMD at baseline, 2-hours, and 4-hours after each meal trial.

HDL-C

时间窗: Through study completion, up to 1 year.

The investigators will measure HDL-C at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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