Blood PressurePhase 1NCT01106170
Efficacy of Provex CV Supplement to Reduce Inflammation Cytokines and Blood Pressure
A Phase 1 study testing Provex CV in people with Blood Pressure, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to determine if a supplement called Provex CV can reduce blood pressure and other risk factors for heart disease. Heart disease is the leading cause of death in this country and it is important to identify dietary factors, including supplements, that can reduce heart disease risk factors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Provex CV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males (18 - 65) and postmenopausal females (up to age 65) with metabolic syndrome who have stage 1 hypertension.
- Since all subjects will have Stage 1 hypertension, they must also meet at least 2 of the following criteria of metabolic syndrome to qualify for the study; waist circumference of >35 inches for women or >40 inches in men, fasting plasma triglycerides of >150 mg/dl, fasting glucose of >100 mg/dl, HDL of <40 in men. Pre-hypertension or greater (130 + mm Hg systolic/80+mm Hg diastolic) is defined by the 7th Report for the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
Who cannot join
- Subjects who are allergic to tea or grapes (on which the supplement is based).
- Participants who have blood pressure less than 130 mmHg / 80 mmHg,
- have a history of a prior cardiovascular event, diabetes, pregnancy, liver disease, renal insufficiency, any chronic disease that might interfere with study participation,
- BMI above 40 kg/m2,
- consumption of >12 alcoholic drinks weekly,
- unwillingness to stop current supplement intake or use of calcium/ magnesium antacids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Crossover Evaluation of a Grape Seed Extract and Quercetin Supplement (Provex CV) to Reduce Markers of Inflammatory Cytokines and Blood Pressure in Subjects With Metabolic Syndrome
The purpose of this study is to determine if a supplement called Provex CV can reduce blood pressure and other risk factors for heart disease. Heart disease is the leading cause of death in this country and it is important to identify dietary factors, including supplements, that can reduce heart disease risk factors. The supplement to be tested in this study is made of a combination of natural compounds found in plants such as grapeseed extract, green tea, and quercetin. Each compound individually has been shown to improve blood pressure or reduce inflammation. We hypothesize that Provex CV will reduce blood pressure and levels of inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. This investigational trial of Provex CV has been approved by the United States Food and Drug Administration.
- Conditions
- Blood Pressure
- Being tested
- Provex CV, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provex CVDrug
dietary supplement, 2 capsules per day by mouth
placeboOther
corn starch, 2 capsules per day by mouth
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will consume 330 mg of Provex CV supplement, by mouth, per day, for 4 weeks followed by 4 weeks of 330 mg of placebo (cornstarch) Receives: Drug: Provex CV; Other: placebo |
| Arm 2 | Experimental | Participants will consume 330 mg placebo (cornstarch), by mouth, per day for 4 weeks followed by 4 weeks of 330 mg of ProvexCV for 4 weeks. Receives: Drug: Provex CV; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 4 weeks after supplement or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thunder Jalili, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106170
- Sponsor's protocol ID
- 31886 Melaluca-ProvexCV
- Status last verified
- Jan 2015
- First submitted
- 15 Apr 2010
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Biesinger S, Michaels HA, Quadros AS, Qian Y, Rabovsky AB, Badger RS, Jalili T. A combination of isolated phytochemicals and botanical extracts lowers diastolic blood pressure in a randomized controlled trial of hypertensive subjects. Eur J Clin Nutr. 2016 Jan;70(1):10-6. doi: 10.1038/ejcn.2015.88. Epub 2015 Jun 10.
PubMed 26059745
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Crossover Evaluation of a Grape Seed Extract and Quercetin Supplement (Provex CV) to Reduce Markers of Inflammatory Cytokines and Blood Pressure in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01106170
- Acronym / sponsor ID
- 31886 Melaluca-ProvexCV
- Conditions
- Blood Pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Apr 2010 (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 this study is to determine if a supplement called Provex CV can reduce blood pressure and other risk factors for heart disease. Heart disease is the leading cause of death in this country and it is important to identify dietary factors, including supplements, that can reduce heart disease risk factors. The supplement to be tested in this study is made of a combination of natural compounds found in plants such as grapeseed extract, green tea, and quercetin. Each compound individually has been shown to improve blood pressure or reduce inflammation. We hypothesize that Provex CV will reduce blood pressure and levels of inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. This investigational trial of Provex CV has been approved by the United States Food and Drug Administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Provex CV, Other: placeboParticipants will consume 330 mg of Provex CV supplement, by mouth, per day, for 4 weeks followed by 4 weeks of 330 mg of placebo (cornstarch) |
| Arm 2 | Experimental | Drug: Provex CV, Other: placeboParticipants will consume 330 mg placebo (cornstarch), by mouth, per day for 4 weeks followed by 4 weeks of 330 mg of ProvexCV for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males (18 - 65) and postmenopausal females (up to age 65) with metabolic syndrome who have stage 1 hypertension.
- Since all subjects will have Stage 1 hypertension, they must also meet at least 2 of the following criteria of metabolic syndrome to qualify for the study; waist circumference of >35 inches for women or >40 inches in men, fasting plasma triglycerides of >150 mg/dl, fasting glucose of >100 mg/dl, HDL of <40 in men. Pre-hypertension or greater (130 + mm Hg systolic/80+mm Hg diastolic) is defined by the 7th Report for the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
Key exclusion criteria (6 listed)
- Subjects who are allergic to tea or grapes (on which the supplement is based).
- Participants who have blood pressure less than 130 mmHg / 80 mmHg,
- have a history of a prior cardiovascular event, diabetes, pregnancy, liver disease, renal insufficiency, any chronic disease that might interfere with study participation,
- BMI above 40 kg/m2,
- consumption of >12 alcoholic drinks weekly,
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 |
|---|---|---|
| Provex CVdietary supplement, 2 capsules per day by mouth | Drug | Arm 1, Arm 2 |
| placebocorn starch, 2 capsules per day by mouth | Other | Arm 1, Arm 2 |
Primary outcome
Blood pressure
Time frame: 4 weeks after supplement or placebo
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 14 Jan 2015.
- Derived from this study: PubMed 26059745Biesinger S, Michaels HA, Quadros AS, Qian Y, Rabovsky AB, Badger RS, Jalili T. A combination of isolated phytochemicals and botanical extracts lowers diastolic blood pressure in a randomized controlled trial of hypertensive subjects. Eur J Clin Nutr. 2016 Jan;70(1):10-6. doi: 10.1038/ejcn.2015.88. Epub 2015 Jun 10.
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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.
Thunder Jalili, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Provex CV in people with Blood Pressure, run by University of Utah 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 2 inclusion and 6 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 14 Jan 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood pressure (time frame: 4 weeks after supplement or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106170, which also lists 1 linked publication.
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 14 Jan 2015.