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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 is currently recruiting participants.
Verified by Sheba Medical Center, August 2006

Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00156169
  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- (PPAR). Upon ligand binding, PPAR 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 -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 -carotene/day. The all-trans to 9-cis -carotene ratio in the capsules is about 1:1.


Condition Intervention Phase
Low HDL Cholesterol
Drug: Dunaliella
Phase III

MedlinePlus related topics:   Cholesterol   

ChemIDplus related topics:   Isotretinoin    Tretinoin    9-cis-Retinoic acid    Lipids    Clofibric acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Crossover Assignment

Further study details as provided by Sheba Medical Center:

Estimated Enrollment:   50
Study Start Date:   May 2001
Estimated Study Completion Date:   September 2005

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156169

Locations
Israel
Institute of lipid & Atherosclerosis Research, Sheba Medical Center     Recruiting
      Tel Hashomer, Israel, 52621
      Contact: Tamar Luvish, RN     972-3-5302940        
      Principal Investigator: Dror Harats, Prof'            
Institute of Lipid & Atherosclerosis Research, Sheba Medical Center     Recruiting
      Tel Hashomer, Israel, 52621
      Contact: tamar luvish, coordinator     972-3-5302940     tamar.luvish@sheba.health.gov    

Sponsors and Collaborators
Sheba Medical Center

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


Study ID Numbers:   SHEBA-01-2358-AH-CTIL
First Received:   September 8, 2005
Last Updated:   August 29, 2006
ClinicalTrials.gov Identifier:   NCT00156169
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:
Clofibric Acid
Alitretinoin
Isotretinoin
Tretinoin

ClinicalTrials.gov processed this record on October 10, 2008




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