NCT00156169

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

Completed Phase 3 Last updated 10 August 2009

What this trial tests

Phase 3 trial testing Dunaliella in Low HDL Cholesterol in 50 participants. Completed in 1 December 2006.

Timeline

1 May 2001

1 December 2006

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Enrollment	50
Start date	1 May 2001
Estimated completion	1 December 2006

Drugs / interventions tested

• Dunaliella — full drug profile →

Conditions studied

• Low HDL Cholesterol — all drugs for Low HDL Cholesterol →

Sponsor

Sheba Medical Center

Who can join

Adults 18 to 70, any sex, with Low HDL Cholesterol. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Natural products targeting inflammation-related metabolic disorders: A comprehensive review.
   Nainu F, Frediansyah A, Mamada SS, Permana AD, et al · · 2023 · cited 22× · PMID 37346355 · DOI 10.1016/j.heliyon.2023.e16919