Effect of pomegranate extract on carotid atherosclerosis
- Conditions
- Atherosclerosis, carotid artery diseaseCirculatory SystemAtherosclerosis
- Registration Number
- ISRCTN30768139
- Lead Sponsor
- POM Wonderful, LLC (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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.
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 <50), dysproteinemia, nephrotic syndrome, or other renal disease
7. Active or chronic hepatobiliary or hepatic disease.
8. Patients with AST or ALT >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of progression/regression of 3-dimensional plaque volume
- Secondary Outcome Measures
Name Time Method 1. Rate of progression/regression of carotid intima-media thickness<br>2. Rate of progression/regression of 3D carotid vessel wall volume<br>3. Change in insulin resistance measured by the HOMA and QUICKI indexes