Hyperinsulinemia Clinical Trial
Official title:
The Movie Theater Study: Acute Cardiometabolic Effects of a Cinema-Style Meal
NCT number | NCT06444984 |
Other study ID # | 2141491-1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 24, 2024 |
Est. completion date | March 2025 |
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).
Status | Recruiting |
Enrollment | 10 |
Est. completion date | March 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Health Professions Building, Ball State University | Muncie | Indiana |
Lead Sponsor | Collaborator |
---|---|
Ball State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. |
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