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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

August 10, 2009

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00156169 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Low HDL Cholesterol

Intervention ^ICMJE

Drug: Dunaliella

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00156169

Responsible Party

Study ID Numbers ^ICMJE

SHEBA-01-2358-AH-CTIL

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ayelet Harari, Phd

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP