Effects of Hoodia on Blood Pressure and Heart Function
Condition: Healthy
Study type: Interventional

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.
    

Intervention name(s): Hoodia Gordonii; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 750 mg capsule will be taken one time; Placebo capsule to be taken one time
Other intervention name(s): Desert Burn
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Human Volunteers; Hoodia; Safety