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

Low HDL Cholesterol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156169
• Other study ID #: SHEBA-01-2358-AH-CTIL
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: August 10, 2009
• Start date: May 2001
• Est. completion date: December 2006

Study information

• Verified date: August 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Low HDL Cholesterol

Intervention

Drug:
• Dunaliella

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center