Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers

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.

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.