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Unable to quantify caffeine
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The purpose of this study determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. Participants will randomly be assigned to consume either one 8oz cup of coffee containing 400mg of caffeine (increased caffeine using concentrated coffee) or one 8oz cup of coffee-flavored drink with approximately 400mg synthetic caffeine from capsules dissolved in it.
The purpose of this study is to assess the difference in effects of consuming synthetic versus natural caffeine on hemodynamic parameters in healthy subjects. This study will determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. The participants in this study are healthy adults who will be introduced to a risk that may be more than they would encounter through their normal daily activities. This study seeks to add to the literature by evaluating the difference in impact of synthetic compared to natural caffeine on central blood pressure.
This protocol has the following aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Caffeine | Experimental | Subjects will be their own control and will have repeated measures after the consumption of a drink with 400mg of natural caffeine. Blood pressure measurements will be taken at baseline, then hourly for four hours. |
|
| Synthetic Caffeine | Experimental | Subjects will be their own control and will have repeated measures after the consumption of a drink with 400mg of synthetic caffeine. Blood pressure measurements will be taken at baseline, then hourly for four hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Caffeine | Dietary Supplement | Consumption of 400mg of natural caffeine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral systolic blood pressure | Two peripheral systolic blood pressure measurements will be taken prior to the consumption of the assigned study drink. Repeated peripheral systolic blood pressure readings will occur twice at each time point hourly for a period of four hours. For each measurement, participant will be asked to rest for five minutes. | Four hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral diastolic blood pressure | Two peripheral diastolic blood pressure measurements will be taken prior to the consumption of the assigned study drink. Repeated peripheral diastolic blood pressure readings will occur twice at each time point hourly for a period of four hours. For each measurement, participant will be asked to rest for five minutes. | Four hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Tesch | David Grant Medical Center | Principal Investigator |
| Sachin A Shah | David Grant Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28446495 | Background | Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448. | |
| 18753650 | Background | Furie B, Furie BC. Mechanisms of thrombus formation. N Engl J Med. 2008 Aug 28;359(9):938-49. doi: 10.1056/NEJMra0801082. No abstract available. |
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This protocol uses a crossover design. The subject sample is randomized. Subjects will serve as their own controls as they will be asked to intake both the natural and synthetic caffeine at two different occasions.
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| Synthetic Caffeine |
| Dietary Supplement |
Consumption of 400mg of synthetic caffeine |
|
| Cardiac output | Cardiac output will be measured prior to the consumption of assigned study drink. Repeated cardiac output readings will occur twice at each time point hourly for a period of four hours. For each measurement, participant will be asked to rest for five minutes. | Four hours |
| 25090963 | Background | Guessous I, Eap CB, Bochud M. Blood pressure in relation to coffee and caffeine consumption. Curr Hypertens Rep. 2014 Sep;16(9):468. doi: 10.1007/s11906-014-0468-2. |
| 15081447 | Background | Hartley TR, Lovallo WR, Whitsett TL. Cardiovascular effects of caffeine in men and women. Am J Cardiol. 2004 Apr 15;93(8):1022-6. doi: 10.1016/j.amjcard.2003.12.057. |
| 27735834 | Background | Knapik JJ, Trone DW, McGraw S, Steelman RA, Austin KG, Lieberman HR. Caffeine Use among Active Duty Navy and Marine Corps Personnel. Nutrients. 2016 Oct 9;8(10):620. doi: 10.3390/nu8100620. |
| 22709816 | Background | Lieberman HR, Stavinoha T, McGraw S, White A, Hadden L, Marriott BP. Caffeine use among active duty US Army soldiers. J Acad Nutr Diet. 2012 Jun;112(6):902-12, 912.e1-4. doi: 10.1016/j.jand.2012.02.001. |
| 22609340 | Background | Marik PE. Noninvasive cardiac output monitors: a state-of the-art review. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):121-34. doi: 10.1053/j.jvca.2012.03.022. Epub 2012 May 19. No abstract available. |