The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.
|ClinicalTrials.gov Identifier: NCT00156169|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 12, 2009
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|
|Low HDL Cholesterol||Drug: Dunaliella||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid|
|Study Start Date :||May 2001|
|Study Completion Date :||December 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156169
|Study Director:||Ayelet Harari, Phd||Sheba Medical Center|