Lipid Profile |
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Clinical Trial: the Effect of the Alga Dunaliella Bardawil as a Sorce of 9-Cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.
This study is currently recruiting patients.
Verified by Sheba Medical Center September 2005
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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 |
MedlinePlus related topics: Metabolic Disorders
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Crossover Assignment
Expected Total Enrollment: 50
Study start: May 2001
Last follow-up: September 2005
Eligibility
Inclusion Criteria:
age 18-70 years Fibrate treatment (for at least 6 weeks) HDL-Cholesterol lower than 40mg/dl. Trigliceride over 150mg/dl. -
Exclusion Criteria:
High CPK. Elevated liver fanction. Active CHD. Smokers. Diabetes patients treated with Insullin or Avandia. HbA1C great than 8.5.
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Location and Contact Information
Israel
Institute of lipid & Atherosclerosis Research, Sheba Medical Center, Tel Hashomer, 52621, Israel; Recruiting
Dror Harats, Prof'''', Principal Investigator
Institute of Lipid & Atherosclerosis Research, Sheba Medical Center, Tel Hashomer, 52621, Israel; Recruiting
Ayelet Harari, Phd, Study Director, Sheba Medical Center
More Information
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00156169
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-13

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