Clinical trial NCT00693264: Effects of Hoodia on Blood Pressure and Heart Function
Official title: The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Human Volunteers
Hoodia
Safety
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2008-06-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to learn about an herbal product called Hoodia gordonii. We want to know if Hoodia gordonii affects blood pressure, heart rate (pulse), heart pressures, and the heart's electrical conduction system. To participate in this study you must be a healthy volunteer with no known medical problems.

Detailed description: If you decide to join this research study you will come in for two visits one week apart. Each visit will last 8 hours (you will not be required to stay in the exam room for the entire day). During the first visit you will be assigned, by chance, like the flip of a coin, to get either Hoodia gordonii or placebo. A placebo is a pill that looks like the herbal supplement but does not have any active ingredients in it. During the second visit you will get either Hoodia or placebo, whichever you did not get during the first visit. Neither you nor your study doctor will know ahead of time if you will get Hoodia or placebo during the first visit.

If you choose to participate in this study you have the following tests performed.

A. Electrocardiogram (ECG): this is a test that measures the electrical activity in the heart. This test involves placing 10 stickers on the chest and stomach and will last about 1 minute.

B. Blood Pressure: this is a test that involves placing a cuff on your arm and inflating it. Blood pressure cuffs might make you feel uncomfortable when they inflate, but it is not painful. The cuff will be placed on your arm for approximately 3 minutes.

C. Hemodynamics: these are tests that measure the pressures in the heart. This test involves placing 4 stickers (2 on your neck and 2 on your stomach) and is done while lying down. This test will last about 3 minutes and will be done at the same time as the blood pressure test.

Each test (A through C) will be performed a total of 10 times (5 times each study visit). Women of child bearing age will be required to take a urine pregnancy test. Pregnant women are not eligible to participate in this study. An outline of a study day is provided below.

1. Arrive at the exam room. ECG, Blood Pressure, and Hemodynamics are measured (for example, 8:00am).
2. Take the study pill (for example, 8:15am).
3. Return to exam room 1 hour after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 9:15am).
4. Return to the exam room 3 hours after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 11:15am).
5. Return to the exam room 5 hours after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 1:15pm).
6. Return to the exam room 8 hours after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 4:15pm).

Return to exam room 1 week later and repeat the day outlined above. Your participation in this study will last 1 week.

Eligibility criteria: Inclusion Criteria:

* Subjects at least 18 years of age and in general good health expressing interest in participating in the study will be evaluated for inclusion.

Exclusion Criteria:

* baseline heart rate less than 50 beats/minute or greater than 100 beats/minute
* heart rhythm other than normal sinus
* history of atrial or ventricular arrhythmia
* family history of premature sudden cardiac death
* left ventricular hypertrophy
* atherosclerosis
* hypertension
* palpitations
* T-wave abnormality
* baseline corrected QT(QTc) interval greater than 440 milliseconds (ms)
* thyroid disease
* type 1 or 2 diabetes mellitus
* recurrent headaches
* depression
* any psychiatric condition or neurological disorder
* history of alcohol or drug abuse
* renal or hepatic dysfunction
* concurrent use of potentially interacting drugs (anticoagulants, MAO inhibitors, CYP 3A impacted drugs (substrate, inducer, or inhibitor) over the counter medications containing pseudoephedrine, caffeine containing products, or any dietary supplements)
* subject unwillingness to sign informed consent
* Pregnant or lactating females will also be also excluded from participation with urine dipstick tests used to confirm lack of pregnancy.

Primary outcomes:
measure: Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals.
timeFrame: Baseline, 1, 3, 5 and 8 hours after taking study drug
Secondary outcomes:
measure: Evaluate other electrocardiographic effects, specifically effects on the QTc, QRS, and Tpe intervals of H. gordonii in healthy individuals.
timeFrame: Baseline, 1, 3, 5, and 8 hours after taking study drug
measure: Evaluate the impact of H. gordonii on the following hemodynamic parameters: Blood Pressure, Cardiac Output, Systemic Vascular Resistance, and Thoracic Fluid Content.
timeFrame: Baseline, 1, 3, 5, and 8 hours after taking study drug.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Nickole N Henyan, PharmD
role: PRINCIPAL_INVESTIGATOR
References: