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

The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid

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.

Study Overview

• Status: Completed
• Conditions: Low HDL Cholesterol
• Intervention / Treatment: Drug: Dunaliella

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): August 12, 2009
• Last Update Submitted That Met QC Criteria: August 10, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: SHEBA-01-2358-AH-CTIL