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The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Unknown status
CT.gov ID
NCT00470808
Collaborator
(none)
1
Location
3
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
May 1, 2007
Anticipated Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males

    • HBA1C>7%

    • Drug therapy given for DM

    Exclusion Criteria:

    • Age<18

    • Inclusion in another study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ha'Emek Medical Center Afula Israel 18101

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    • Principal Investigator: Wasseem Rock, MD, Ha'Emek Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00470808
    Other Study ID Numbers:
    • 0051-07-EMC
    First Posted:
    May 8, 2007
    Last Update Posted:
    May 8, 2007
    Last Verified:
    Apr 1, 2007
    Keywords provided by , ,
    Minors
    Enrollment in another study
    Males
    HBA1C greater than 7
    Drug therapy for DM
    Additional relevant MeSH terms:
    Atherosclerosis

    Study Results

    No Results Posted as of May 8, 2007