The Effect of the Alga Dunaliella Bardawil as a Source of 9-Cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low HDL Cholesterol
Intervention: Dunaliella (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Ayelet Harari, Phd, Study Director, Affiliation: Sheba Medical Center
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- (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.
Clinical Details
Study design: Randomized, Double-Blind, Placebo Control, Crossover Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Institute of lipid & Atherosclerosis Research, Sheba Medical Center, Tel Hashomer 52621, Israel; Recruiting
Tamar Luvish, RN, Phone: 972-3-5302940
Dror Harats, Prof', Principal Investigator
Institute of Lipid & Atherosclerosis Research, Sheba Medical Center, Tel Hashomer 52621, Israel; Recruiting
tamar luvish, coordinator, Phone: 972-3-5302940, Email: tamar.luvish@sheba.health.gov
Additional Information
Starting date: May 2001
Ending date: September 2005
Last updated: August 29, 2006
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