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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
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low HDL Cholesterol

Intervention: Dunaliella (Drug)

Phase: Phase 3

Status: Completed

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-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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

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

Additional Information

Starting date: May 2001
Last updated: August 10, 2009

Page last updated: August 23, 2015

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