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Effects of Hoodia on Blood Pressure and Heart Function

NCT ID: NCT00693264

Last Updated: 2009-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Human Volunteers Hoodia Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Participants will take 1- 750 mg capsule of Hoodia gordonii and have the primary and secondary outcomes measured over an 8 hour visit.

Group Type EXPERIMENTAL

Hoodia Gordonii

Intervention Type DIETARY_SUPPLEMENT

750 mg capsule will be taken one time

2

Participants will take a placebo capsule and have the primary and secondary outcome measures taken over an 8 hour study day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule to be taken one time

Interventions

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Hoodia Gordonii

750 mg capsule will be taken one time

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule to be taken one time

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Desert Burn

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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University of Mississippi Medical Center

Principal Investigators

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Nickole N Henyan, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2008-0005

Identifier Type: -

Identifier Source: org_study_id