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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00156169
First received: September 8, 2005
Last updated: August 10, 2009
Last verified: August 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 50
Study Start Date: May 2001
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156169

Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Ayelet Harari, Phd Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156169     History of Changes
Other Study ID Numbers: SHEBA-01-2358-AH-CTIL
Study First Received: September 8, 2005
Last Updated: August 10, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Isotretinoin
Tretinoin
Alitretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on April 15, 2014