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

Phase 3

Completed

• Conditions: Low HDL Cholesterol

• Registration Number: NCT00156169
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Study Completion: 2006-12
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-10
• Last Update Posted: 2009-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER