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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156169
First Posted: September 12, 2005
Last Update Posted: August 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

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 Intervention Phase
Low HDL Cholesterol Drug: Dunaliella Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 50
Study Start Date: May 2001
Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156169


Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Ayelet Harari, Phd Sheba Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00156169     History of Changes
Other Study ID Numbers: SHEBA-01-2358-AH-CTIL
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: August 12, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Alitretinoin
Tretinoin
Isotretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents