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The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.

Sponsor
Sheba Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00156169
Collaborator
(none)
50
Enrollment
67
Duration (Months)

Study Details

Study Description

Brief Summary

The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor-g (PPARg). Upon ligand binding, PPARg heterodimerizes with the 9-cis retinoic acid receptor (RXR), and the heterodimer regulates gene expression. We assessed the hypothesis that a dual treatment with fibrate plus 9-cis b-carotene-rich powder of the alga Dunaliella bardawil, as a source of 9-cis retinoic acid, would improve the drug's effect on HDL-cholesterol levels.

patients with plasma HDL-cholesterol levels below 40 mg/dl and triglyceride (TG) levels above 200 mg/dl after fibrate treatment (for at least 6 weeks). are given four capsules of Dunaliella, providing 60 mg b-carotene/day. The all-trans to 9-cis b-carotene ratio in the capsules is about 1:1.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Official Title:
The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid
Study Start Date :
May 1, 2001
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age 18-70 years

    • Fibrate treatment (for at least 6 weeks)

    • HDL-Cholesterol lower than 40mg/dl.

    • Triglyceride over 150mg/dl.

    Exclusion Criteria:

    • High CPK.

    • Elevated liver functions.

    • Active CHD.

    • Smokers.

    • Diabetes patients treated with Insulin or Avandia. HbA1C great than 8.5.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Study Director: Ayelet Harari, Phd, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00156169
    Other Study ID Numbers:
    • SHEBA-01-2358-AH-CTIL
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Aug 12, 2009
    Last Verified:
    Aug 1, 2009

    Study Results

    No Results Posted as of Aug 12, 2009