HealthyNCT00693264
Effects of Hoodia on Blood Pressure and Heart Function
A study testing Hoodia Gordonii in people with Healthy, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hoodia Gordonii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects at least 18 years of age and in general good health expressing interest in participating in the study will be evaluated for inclusion.
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers
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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Healthy
- Being tested
- Hoodia Gordonii, Placebo
- Keywords
- Human Volunteers, Hoodia, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hoodia GordoniiDietary supplement
Also called Desert Burn
750 mg capsule will be taken one time
PlaceboDietary supplement
Placebo capsule to be taken one time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Hoodia Gordonii |
| 2 | Placebo comparator | Participants will take a placebo capsule and have the primary and secondary outcome measures taken over an 8 hour study day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals.
Measured: Baseline, 1, 3, 5 and 8 hours after taking study drug
Secondary outcomes (2)
Evaluate other electrocardiographic effects, specifically effects on the QTc, QRS, and Tpe intervals of H. gordonii in healthy individuals.
Measured: 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.
Measured: Baseline, 1, 3, 5, and 8 hours after taking study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Nickole N Henyan, PharmD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693264
- Sponsor's protocol ID
- 2008-0005
- Status last verified
- Mar 2009
- First submitted
- 5 Jun 2008
- Last updated
- 30 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00693264
- Acronym / sponsor ID
- 2008-0005
- Conditions
- Healthy
- Keywords
- Human Volunteers, Hoodia, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Hoodia GordoniiParticipants will take 1- 750 mg capsule of Hoodia gordonii and have the primary and secondary outcomes measured over an 8 hour visit. |
| 2 | Placebo comparator | Dietary Supplement: PlaceboParticipants will take a placebo capsule and have the primary and secondary outcome measures taken over an 8 hour study day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects at least 18 years of age and in general good health expressing interest in participating in the study will be evaluated for inclusion.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hoodia GordoniiAlso: Desert Burn750 mg capsule will be taken one time | Dietary supplement | 1 |
| PlaceboPlacebo capsule to be taken one time | Dietary supplement | 2 |
Primary outcome
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
2 secondary outcomes
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nickole N Henyan, PharmD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hoodia Gordonii in people with Healthy, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2009.