Effects of Hoodia on Blood Pressure and Heart Function - Full Text View

Sponsored by:	University of Mississippi Medical Center
Information provided by:	University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT00693264

Purpose

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.

Condition	Intervention
Healthy	Dietary Supplement: Hoodia Gordonii Dietary Supplement: Placebo

MedlinePlus related topics: Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study
Official Title:	The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	15
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Dietary Supplement: Hoodia Gordonii 750 mg capsule will be taken one time
2: Placebo Comparator 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

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 abnormalitie
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693264

Contacts

Contact: Nickole N Henyan, PharmD	601-984-2615	nhenyan@sop.umsmed.edu
Contact: Daniel M Riche, PharmD	601-984-2640	driche@sop.umsmed.edu

Locations

United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
Contact: Michelle Richard mmrichard@umsmed.edu
Sub-Investigator: Daniel M Riche, PharmD
Principal Investigator: Nickole N Henyan, PharmD
Sub-Investigator: Honey E East, MD

Sponsors and Collaborators

University of Mississippi Medical Center

Investigators

Principal Investigator:

Nickole N Henyan, PharmD

University of Mississippi Medical Center

More Information

Responsible Party:	University of Mississippi Medical Center ( Nickole Henyan/Assistant Professor of Pharmacy Practice )
Study ID Numbers:	2008-0005
Study First Received:	June 5, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00693264
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

Human Volunteers
Hoodia
Safety

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009