Condition category
Circulatory System
Date applied
26/05/2012
Date assigned
03/07/2012
Last edited
03/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
To find out if pomegranate extract is good for the arteries.

Who can participate?
Patients attending the Stroke Prevention & Atherosclerosis Research Centre, at Western University, Canada, who have had ultrasound scans of their carotid arteries and are known to have plaque (a build up of cholesterol and fats) in the arteries are eligible for the study.

What does the study involve?
Participants will have an ultrasound scan of the carotid arteries before and one year after being randomized to take a tablet of pomegranate extract, or an inactive placebo once daily for a year. The ultrasound scan measures the amount of plaque in the arteries, and to see how quickly it worsens or improves over a year on the two treatments.

What are the possible benefits and risks of participating?
The main benefit is that participants will help contribute to new knowledge of how to prevent heart attacks and strokes. It is possible that patients randomized to pomegranate extract might have less worsening of their arteries during the year of the study, but that is unknown – that’s why the study needs to be done.

Where is the study run from?
Stroke Prevention & Atherosclerosis Research Centre (SPARC), Western University, Ontario, Canada

When is study starting and how long is it expected to run for?
July 2012 to July 2014

Who is funding the study?
POM Wonderful

Who is the main contact?
Tisha Mabb
tisha@robarts.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. David Spence

ORCID ID

Contact details

Stroke Prevention & Atherosclerosis Research Centre
1400 Western Road
London
Ontario
N6G 2V2
Canada
+1 (519) 931 5731
dspence@robarts.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

POMSPARC 1

Study information

Scientific title

A randomized, double-blind study to evaluate the effect of pomegranate extract on carotid atherosclerosis in patients with carotid artery disease

Acronym

POMPlaque Study

Study hypothesis

Pomegranate extract will slow the progression of carotid atherosclerosis compared to placebo.

Ethics approval

Human Research Ethics Board, Western University, Ontario, Canada

Study design

Double-blind randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atherosclerosis, carotid artery disease

Intervention

Pomegranate extract, 1000mg or an inactive placebo once daily for a year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rate of progression/regression of 3-dimensional plaque volume

Secondary outcome measures

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

Overall trial start date

02/07/2012

Overall trial end date

30/07/2014

Reason abandoned

Eligibility

Participant 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, α-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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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 <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

Recruitment start date

02/07/2012

Recruitment end date

30/07/2014

Locations

Countries of recruitment

Canada

Trial participating centre

Stroke Prevention & Atherosclerosis Research Centre
Ontario
N6G 2V2
Canada

Sponsor information

Organisation

POM Wonderful, LLC (USA)

Sponsor details

11444 West Olympic Boulevard
Los Angeles
90064
United States of America

Sponsor type

Industry

Website

http://www.pomwonderful.com/

Funders

Funder type

Industry

Funder name

POM Wonderful (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes