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

NCT00728299 | Completed

• 1 other identifier: Radiant Development #202528
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease, carotid intima-media thickness

Outcome Measures

Primary Outcomes (1)

• Difference in posterior wall common carotid intima-media thickness (IMT) progression rate in mm/yr between PomWonderful juice and placebo, utilizing non-contrast images

  78-90 weeks

Secondary Outcomes (7)

• Difference between placebo and PomWonderful juice in internal carotid artery IMT progression rate in mm/yr

  78-90 weeks

• Difference between placebo and PomWonderful juice in the carotid bifurcation IMT progression rate in mm/yr

  78-90 weeks

• Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, without contrast agent

  78-90 weeks

• Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, with contrast agent

  78-90 weeks

• Difference between placebo and PomWonderful juice in the posterior wall common carotid IMT progression rate in mm/yr, with contrast agent

  78-90 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: PomWonderful Juice

2

PLACEBO COMPARATOR

Drug: Placebo juice

Interventions

PomWonderful Juice DRUG

8 oz per day each day for 78 weeks

1

Placebo juice DRUG

8 oz per day for 78 weeks

2

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Radiant Research: lead
• Roll International Corporation: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Michael H Davidson, MD

  FACC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: September 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: August 5, 2008

Record last verified: 2008-08