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

This study is currently recruiting participants.

Verified by Sheba Medical Center, August 2006

First Received: September 8, 2005 Last Updated: August 29, 2006 History of Changes

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00156169

Purpose

The effect of fibrates on high density lipoprotein (HDL)-cholesterol levels is suggested to be mediated by its binding to peroxisome proliferator-activated receptor- (PPAR). Upon ligand binding, PPAR 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 -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 -carotene/day. The all-trans to 9-cis -carotene ratio in the capsules is about 1:1.

Condition	Intervention	Phase
Low HDL Cholesterol	Drug: Dunaliella	Phase III

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment:	50
Study Start Date:	May 2001
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156169

Locations

Israel
Institute of lipid & Atherosclerosis Research, Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Contact: Tamar Luvish, RN 972-3-5302940
Principal Investigator: Dror Harats, Prof'
Institute of Lipid & Atherosclerosis Research, Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Contact: tamar luvish, coordinator 972-3-5302940 tamar.luvish@sheba.health.gov

Sponsors and Collaborators

Sheba Medical Center

Investigators

Study Director:

Ayelet Harari, Phd

Sheba Medical Center

More Information

No publications provided

Study ID Numbers:	SHEBA-01-2358-AH-CTIL
Study First Received:	September 8, 2005
Last Updated:	August 29, 2006
ClinicalTrials.gov Identifier:	NCT00156169 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Clofibric Acid
Alitretinoin
Isotretinoin
Tretinoin

ClinicalTrials.gov processed this record on July 02, 2009