Atherosclerosis, carotid artery disease Circulatory System Atherosclerosis
Conditions
Interventions
Pomegranate extract, 1000mg or an inactive placebo once daily for a year.
Sponsors
POM Wonderful, LLC (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects, 18 years old and above 2. Patients with carotid plaque, as measured by 3-D ultrasound, having a mean baseline plaque volume of 200 mm3 (minimum of 100 mm3 and maximum of 900 mm3) 3. Subjects must be willing to give written informed consent and able to adhere to dosing schedule, visit schedule and phone follow-up assessment. 4. Subjects? clinical laboratory tests (CBC, blood chemistries and urinalysis) must be within normal limits or clinically acceptable to the investigator. 5. Subjects must be free of any clinically significant disease that would interfere with the study evaluations. 6. Female subjects of childbearing potential must be using a medically accepted method of birth control prior to the first clinic visit and agree to continue its use during the study, or have been surgically sterilized (e.g. hysterectomy or tubal ligation). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study. 7. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. 8. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at the first clinic visit. 9. Patients on cardiovascular medications will be allowed to enter the study provided that they are on a stable medication regimen for at least 6 weeks prior study entry and patients agree to remain on the same regimen for the duration of the study. Medications permitted include: lipid lowering drugs, antihypertensive drugs, multiple vitamins, beta-blockers, calcium-channel blockers, ACE inhibitors, nitrates, a-adrenergic blockers, thiazide diuretics, antiplatelet agents, or anticoagulants (e.g. warfarin) 10. Patients on a stable diet for at least 4 weeks prior entry into the study and willing to maintain this diet for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant, intend to become pregnant, or are nursing 2. Subjects, who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study 3. Individuals with a history of mental instability, drug or alcohol abuse or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study 4. Excessive alcohol consumption (more than 2 glasses per day or 14 glasses per week) or history of alcohol or drug abuse within the past 2 years. 5. Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation 6. Known impairment of renal function (eGFR 2 x upper limit of the laboratory reference range 9. Patients who are known to have tested positive for human immunodeficiency virus (HIV) 10. Patients who are currently enrolled in another clinical drug study 11. Patients who have used any investigational drug within 30 days of the first clinic visit 12. Congestive heart failure NYHA Class III or IV 13. Uncontrolled cardiac arrhythmias within 3 months of study entry 14. Myocardial infarction or coronary bypass surgery or angioplasty within 3 months of study entry 15. Unstable or severe peripheral artery disease within 3 months of study entry 16. Unstable angina pectoris within 3 months of study entry 17. Type I or Type II diabetes mellitus that is poorly controlled (HbA1c > 9.0%) or newly diagnosed (within 3 months) or a change in antidiabetic pharmacotherapy [i.e. changes in dosage (with the exception of ± 10 units of insulin) or addition of new medication] within 3 months of screening or patients experiencing recent history of repeated hypoglycemia or unstable glycemic control. 18. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of progression/regression of 3-dimensional plaque volume | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of progression/regression of carotid intima-media thickness 2. Rate of progression/regression of 3D carotid vessel wall volume 3. Change in insulin resistance measured by the HOMA and QUICKI indexes | — |
Countries
Canada
Outcome results
None listed