The Effects of Consumption of Pomegranate Juice on Carotid Intima-Media Thickness

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary artery disease, carotid intima-media thickness Read More

Inclusion Criteria:

• 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 Criteria:

• 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).