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

Sheba Medical Center

Status and phase: Completed; Phase 3

Conditions: Low HDL Cholesterol

Treatments: Drug: Dunaliella

Study type: Interventional

Funder types: Other

Identifiers

NCT00156169

SHEBA-01-2358-AH-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.