Status:
COMPLETED
The Effects of Consumption of Pomegranate Juice on Carotid Intima-Media Thickness
Lead Sponsor:
Radiant Research
Collaborating Sponsors:
Roll International Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
45-74 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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,
- 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).
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00728299
Start Date
September 1 2003
End Date
September 1 2005
Last Update
August 5 2008
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