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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00156169

Enrollment

Registered

2005-09-12

Start date

2001-05-31

Completion date

2006-12-31

Last updated

2009-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low HDL Cholesterol

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.

Interventions

DRUGDunaliella

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026