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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.
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.
Return to exam room 1 week later and repeat the day outlined above. Your participation in this study will last 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will take 1- 750 mg capsule of Hoodia gordonii and have the primary and secondary outcomes measured over an 8 hour visit. |
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| 2 | Placebo Comparator | Participants will take a placebo capsule and have the primary and secondary outcome measures taken over an 8 hour study day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hoodia Gordonii | Dietary Supplement | 750 mg capsule will be taken one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals. | Baseline, 1, 3, 5 and 8 hours after taking study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate other electrocardiographic effects, specifically effects on the QTc, QRS, and Tpe intervals of H. gordonii in healthy individuals. | Baseline, 1, 3, 5, and 8 hours after taking study drug | |
| Evaluate the impact of H. gordonii on the following hemodynamic parameters: Blood Pressure, Cardiac Output, Systemic Vascular Resistance, and Thoracic Fluid Content. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nickole N Henyan, PharmD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| Placebo | Dietary Supplement | Placebo capsule to be taken one time |
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| Baseline, 1, 3, 5, and 8 hours after taking study drug. |