Effects of Hoodia on Blood Pressure and Heart Function
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers|
- Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals. [ Time Frame: Baseline, 1, 3, 5 and 8 hours after taking study drug ] [ Designated as safety issue: Yes ]
- Evaluate other electrocardiographic effects, specifically effects on the QTc, QRS, and Tpe intervals of H. gordonii in healthy individuals. [ Time Frame: Baseline, 1, 3, 5, and 8 hours after taking study drug ] [ Designated as safety issue: Yes ]
- Evaluate the impact of H. gordonii on the following hemodynamic parameters: Blood Pressure, Cardiac Output, Systemic Vascular Resistance, and Thoracic Fluid Content. [ Time Frame: Baseline, 1, 3, 5, and 8 hours after taking study drug. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Participants will take 1- 750 mg capsule of Hoodia gordonii and have the primary and secondary outcomes measured over an 8 hour visit.
Dietary Supplement: Hoodia Gordonii
750 mg capsule will be taken one time
Other Name: Desert Burn
Placebo Comparator: 2
Participants will take a placebo capsule and have the primary and secondary outcome measures taken over an 8 hour study day.
Dietary Supplement: Placebo
Placebo capsule to be taken one time
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.
- Arrive at the exam room. ECG, Blood Pressure, and Hemodynamics are measured (for example, 8:00am).
- Take the study pill (for example, 8:15am).
- Return to exam room 1 hour after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 9:15am).
- Return to the exam room 3 hours after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 11:15am).
- Return to the exam room 5 hours after taking the study pill to have ECG, Blood Pressure, and hemodynamics measured (for example, 1:15pm).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693264
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Nickole N Henyan, PharmD||University of Mississippi Medical Center|