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

S

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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