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 \[weeks 13, 26, 38, 52, 65, and 78\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
384
8 oz per day each day for 78 weeks
8 oz per day for 78 weeks
Difference in posterior wall common carotid intima-media thickness (IMT) progression rate in mm/yr between PomWonderful juice and placebo, utilizing non-contrast images
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in internal carotid artery IMT progression rate in mm/yr
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the carotid bifurcation IMT progression rate in mm/yr
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, without contrast agent
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the anterior wall common carotid IMT progression rate in mm/yr, with contrast agent
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the posterior wall common carotid IMT progression rate in mm/yr, with contrast agent
Time frame: 78-90 weeks
Difference between placebo and PomWonderful juice in the composite IMT measure, which combines the measurements of the common and internal carotid and the carotid bifurcation in mm/yr
Time frame: 78-90 weeks
Change from baseline to 13 weeks in hs-CRP concentration
Time frame: 13 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.