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| Sponsor: | 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-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.
| Condition | Intervention | Phase |
|---|---|---|
|
Low HDL Cholesterol |
Drug: Dunaliella |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment |
| Official Title: | The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | SHEBA-01-2358-AH-CTIL |
| Study First Received: | September 8, 2005 |
| Last Updated: | August 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00156169 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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