NCT00728299

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Radiant Research · Academic / Other
• Sex: All
• Age: 45 Years – 74 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	PomWonderful Juice	8 oz per day each day for 78 weeks
DRUG	Placebo juice	8 oz per day for 78 weeks

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2008-08-05
• Last updated: 2008-08-05