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

NCT ID: NCT00156169

Last Updated: 2009-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2006-12-31

Brief 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.

Conditions

Low HDL Cholesterol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Interventions

Dunaliella

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ayelet Harari, Phd

Role: STUDY_DIRECTOR

Sheba Medical Center

Other Identifiers

SHEBA-01-2358-AH-CTIL

Identifier Type: -

Identifier Source: org_study_id