Clinical trial NCT03495063: Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers
Official title: Comparison of Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers: A Randomized, Double Blind, Crossover Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Injury
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2018-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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:

1. Investigators hypothesize there will be a (baseline adjusted \[ΔBP\]) difference in BP (peripheral and central) between the natural and synthetic caffeine arms in healthy volunteers post consumption.
2. Investigators hypothesize there will be (baseline adjusted \[ΔCO\]) no difference in CO between the natural and synthetic caffeine arms in healthy volunteers post consumption.
3. Investigators hypothesize there will be (baseline adjusted \[ΔSVR\]) no difference in SVR between the natural and synthetic caffeine arms in healthy volunteers hours post consumption.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* Active duty military service members
* DoD beneficiaries
* Participants must be willing to refrain from caffeine use 72 hours prior to study days one and five

Exclusion Criteria:

* Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, acute myocardial ischemia, atherosclerosis, hypertension, and palpitations. This will be determined through the questionnaire responses of the participant and thorough chart review.
* Blood pressure at initial screening appointment or at baseline on study Day One greater than 130/80 and if 130-139/80-89, FRS risk greater than 10%.
* Presence of any known medical condition, confirmed through participant interview up to the discretion of the research team. Examples of these are:
* Hypertension
* Thyroid disease
* Type 1 or 2 Diabetes Mellitus
* Recurrent headaches
* Any psychiatric condition or neurological disorder including seizures
* History of alcohol or drug abuse in the previous five years
* Ever been diagnosed or told they have or had renal or hepatic dysfunction
* Tobacco use
* Concurrent use of any medication taken in an amount greater than twice a week, to include herbal products or supplements, not to include hormonal contraceptives. If less than or equal to two days per week, the investigator will determine if the subject is to be included or excluded based on the available literature for that medication.
* Pregnant or lactating females will be excluded from participation with urine dipstick tests used to rule out pregnancy (pregnancy test performed before each treatment session, days one, five)
* All non-English speaking/writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
* If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.
* Allergy to any substance in the study design.
* Any other medical reason that at the discretion of the investigators would pose a risk to the health of the subject.

Primary outcomes:
measure: Peripheral systolic blood pressure
timeFrame: Four hours
Secondary outcomes:
measure: Change in peripheral diastolic blood pressure
timeFrame: Four hours
measure: Cardiac output
timeFrame: Four hours
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
Study officials:
affiliation: David Grant Medical Center
name: Elizabeth A Tesch
role: PRINCIPAL_INVESTIGATOR
affiliation: David Grant Medical Center
name: Sachin A Shah
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.