Coronary Artery DiseaseNCT00728299
The Effects of Consumption of Pomegranate Juice on Carotid Intima-Media Thickness
A study testing PomWonderful Juice in people with Coronary Artery Disease, run by Radiant Research.
Trial summary
Increases in carotid artery intima-media thickness (IMT) are correlated with increased risk of stroke and myocardial infarction. The purpose of this study is to assess if pomegranate juice will retard the carotid (IMT) progression rate in men and women who have one or more existing cardiovascular risk factors (current… Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PomWonderful Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Sep 2005
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males between the ages of 45 and 74 and females between the ages of 55 and 74 years.
- Subject has ≥ 1 of the following risk factors at Visit 1 (week -4 to -1):
- current cigarette smoking (defined as any cigarette smoking within the past month)
- hypertension (blood pressure ≥ 140/90 mm Hg or using an antihypertensive medication)
- low HDL cholesterol (< 40 mg/dL)
- high LDL cholesterol (≥ 130 mg/dL and < 190 mg/dL), on statin therapy or not
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- Posterior wall common carotid IMT > 0.7 mm and < 2.0 mm at Visit 2 (week 0) with an adequate image on at least one side.
- Subject understands the study procedures and signs an informed consent form.
- Normally active and judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests.
Who cannot join
- Use of any pharmacologic lipid-altering medications, besides statins (e.g., fibrate derivatives, bile acid binding resins, and niacin or its analogues at doses > 400 mg/d) six weeks prior to Visit 1
- Body mass index > 40 kg/m2.
- Unstable use (< 2 months prior to Visit 1) of any supplement known to alter lipid metabolism, including but not limited to: dietary fiber supplements (including > 2 teaspoons Metamucil® or psyllium-containing supplement per day), omega-3 fatty acid supplements, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements or others at the discretion of the Investigator).
- History of pomegranate consumption (either eating pomegranates or drinking pomegranate juice) within the past 6 months.
- Clinical evidence or history of coronary heart disease (CHD) or CHD equivalents including:
- diabetes mellitus,
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- angina,
- myocardial infarction,
- transient ischemic attack,
- symptomatic carotid artery disease,
- cerebrovascular accident,
- coronary artery bypass grafting,
- percutaneous transluminal coronary angioplasty,
- peripheral arterial disease,
- abdominal aortic aneurysm,
- ankle brachial index < 0.90,
- and/or a Framingham Risk Score ≥ 16 points for men and ≥ 23 points for women (10-year CHD risk > 20%)
- Active cancer, other than non-melanoma skin cancer, within the previous two years.
- Prior diagnosis of human immunodeficiency virus (HIV) or hepatitis B or hepatitis C.
- Uncontrolled hypertension (average systolic blood pressure ≥ 160 mm Hg and/or average diastolic blood pressure ≥ 100 mm Hg).
- Untreated or unstable hypothyroidism (receiving stable dose therapy for < 4.0 months).
- Concomitant use of beta-adrenergic blockers or immunosuppressants
- Concomitant use of estrogen or progestin therapy.
- Allergy to pomegranates or pomegranate juice.
- Known allergy to blood products.
- Non-English speaking.
- Active liver disease or hepatic dysfunction as defined by elevations of ≥ 2.0 x ULN at Visit 1 in any of the following liver function tests: ALT, AST or bilirubin.
- Serum creatinine > 2.0 mg/dL recorded during screening period.
- Recent history of (within past 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1 ½ oz distilled spirits).
- Participation in another clinical study within 30 days prior to screening visit 1 (week -4 to -1).
- Has a condition the Investigator believes would interfere with evaluation of the subject, or may put subject at undue risk.
- Posterior wall common carotid IMT ≥ 2.0 mm on either side at Visit 2 (week 0).
About this study
Increases in carotid artery intima-media thickness (IMT) are correlated with increased risk of stroke and myocardial infarction. The purpose of this study is to assess if pomegranate juice will retard the carotid (IMT) progression rate in men and women who have one or more existing cardiovascular risk factors (current cigarette smoking, hypertension, low HDL-cholesterol, and/or high LDL-cholesterol) upon entrance into the study.
Read the detailed description
Previous studies in atherosclerotic mice have shown that pomegranate supplementation reduced their macrophage oxidative stress and attenuated the development of their atherosclerosis. Further research in hypertensive humans demonstrated that pomegranate juice had an angiotensin converting enzyme (ACE)-inhibitory effect and significantly decreased systolic blood pressure.
This study will use a randomized, double-blind, placebo-controlled design with eight clinic visits (one screening visit [week -4 to -1], one baseline visit [week 0], and six treatment visits [weeks 13, 26, 38, 52, 65, and 78]).
- Conditions
- Coronary Artery Disease
- Being tested
- PomWonderful Juice, Placebo juice
- Keywords
- Coronary artery disease, carotid intima-media thickness
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomWonderful JuiceDrug
8 oz per day each day for 78 weeks
Placebo juiceDrug
8 oz per day for 78 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PomWonderful Juice |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in posterior wall common carotid intima-media thickness (IMT) progression rate in mm/yr between PomWonderful juice and placebo, utilizing non-contrast images
Measured: 78-90 weeks
Secondary outcomes (7)
Difference between placebo and PomWonderful juice in internal carotid artery IMT progression rate in mm/yr
Measured: 78-90 weeks
Difference between placebo and PomWonderful juice in the carotid bifurcation IMT progression rate in mm/yr
Measured: 78-90 weeks
Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, without contrast agent
Measured: 78-90 weeks
Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, with contrast agent
Measured: 78-90 weeks
Difference between placebo and PomWonderful juice in the posterior wall common carotid IMT progression rate in mm/yr, with contrast agent
Measured: 78-90 weeks
Difference between placebo and PomWonderful juice in the composite IMT measure, which combines the measurements of the common and internal carotid and the carotid bifurcation in mm/yr
Measured: 78-90 weeks
Change from baseline to 13 weeks in hs-CRP concentration
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startSep 2003
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiant Research
- Sponsor type
- University, hospital or other
- Collaborators
- Roll International Corporation
- Investigators
- Michael H Davidson, MD, Principal investigator, FACC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728299
- Sponsor's protocol ID
- Radiant Development #202528
- Status last verified
- Aug 2008
- First submitted
- 31 Jul 2008
- Last updated
- 5 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Consumption of Pomegranate Juice on Carotid Intima-Media Thickness
- ClinicalTrials.gov ID
- NCT00728299
- Acronym / sponsor ID
- Radiant Development #202528
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, carotid intima-media thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Radiant ResearchUniversity, hospital or other
- Collaborators
- Roll International Corporation
- Study start
- Sep 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 5 Aug 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.
Increases in carotid artery intima-media thickness (IMT) are correlated with increased risk of stroke and myocardial infarction. The purpose of this study is to assess if pomegranate juice will retard the carotid (IMT) progression rate in men and women who have one or more existing cardiovascular risk factors (current cigarette smoking, hypertension, low HDL-cholesterol, and/or high LDL-cholesterol) upon entrance into the study.
Detailed description
Previous studies in atherosclerotic mice have shown that pomegranate supplementation reduced their macrophage oxidative stress and attenuated the development of their atherosclerosis. Further research in hypertensive humans demonstrated that pomegranate juice had an angiotensin converting enzyme (ACE)-inhibitory effect and significantly decreased systolic blood pressure.
This study will use a randomized, double-blind, placebo-controlled design with eight clinic visits (one screening visit [week -4 to -1], one baseline visit [week 0], and six treatment visits [weeks 13, 26, 38, 52, 65, and 78]).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PomWonderful Juice |
| 2 | Placebo comparator | Drug: Placebo juice |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males between the ages of 45 and 74 and females between the ages of 55 and 74 years.
- Subject has ≥ 1 of the following risk factors at Visit 1 (week -4 to -1):
- Posterior wall common carotid IMT > 0.7 mm and < 2.0 mm at Visit 2 (week 0) with an adequate image on at least one side.
- Subject understands the study procedures and signs an informed consent form.
- Normally active and judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests.
Key exclusion criteria (32 listed)
- Use of any pharmacologic lipid-altering medications, besides statins (e.g., fibrate derivatives, bile acid binding resins, and niacin or its analogues at doses > 400 mg/d) six weeks prior to Visit 1
- Body mass index > 40 kg/m2.
- Unstable use (< 2 months prior to Visit 1) of any supplement known to alter lipid metabolism, including but not limited to: dietary fiber supplements (including > 2 teaspoons Metamucil® or psyllium-containing supplement per day), omega-3 fatty acid supplements, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements or others at the discretion of the Investigator).
- History of pomegranate consumption (either eating pomegranates or drinking pomegranate juice) within the past 6 months.
- Clinical evidence or history of coronary heart disease (CHD) or CHD equivalents including:
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 |
|---|---|---|
| PomWonderful Juice8 oz per day each day for 78 weeks | Drug | 1 |
| Placebo juice8 oz per day for 78 weeks | Drug | 2 |
Primary outcome
Difference in posterior wall common carotid intima-media thickness (IMT) progression rate in mm/yr between PomWonderful juice and placebo, utilizing non-contrast images
Time frame: 78-90 weeks
7 secondary outcomes
Difference between placebo and PomWonderful juice in internal carotid artery IMT progression rate in mm/yr
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the carotid bifurcation IMT progression rate in mm/yr
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, without contrast agent
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, with contrast agent
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the posterior wall common carotid IMT progression rate in mm/yr, with contrast agent
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the composite IMT measure, which combines the measurements of the common and internal carotid and the carotid bifurcation in mm/yr
Time frame: 78-90 weeks
Change from baseline to 13 weeks in hs-CRP concentration
Time frame: 13 weeks
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 5 Aug 2008.
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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.
Michael H Davidson, MD principal investigator
FACC
Questions about this trial
What is this clinical trial studying?
A study testing PomWonderful Juice in people with Coronary Artery Disease, run by Radiant Research.
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 9 inclusion and 32 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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Difference in posterior wall common carotid intima-media thickness (IMT) progression rate in mm/yr between PomWonderful juice and placebo, utilizing non-contrast images (time frame: 78-90 weeks). 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 5 Aug 2008.