Coronary Artery Disease Clinical Trial
Official title:
The Effects of Consumption of Pomegranate Juice on Carotid Intima-Media Thickness
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.
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]).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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