NCT00470808

Brief Summary

Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 8, 2007

Status Verified

April 1, 2007

First QC Date

May 7, 2007

Last Update Submit

May 7, 2007

Conditions

Atherosclerosis

Keywords

MinorsEnrollment in another studyMalesHBA1C greater than 7Drug therapy for DM

Interventions

POMxDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • HBA1C\>7%
  • Drug therapy given for DM

You may not qualify if:

  • Age\<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ha'Emek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wasseem Rock, MD

    Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasseem Rock, MD

CONTACT

0547866896wasseem_rock@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

May 1, 2007

Study Completion

August 1, 2007

Last Updated

May 8, 2007

Record last verified: 2007-04

Locations

IL(1)