Low HDL CholesterolPhase 3NCT00156169
The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid on Lipid Profile in Fibrate Treated Patients.
A Phase 3 study testing Dunaliella in people with Low HDL Cholesterol, run by Sheba Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low HDL Cholesterol
- What is being tested?
- Dunaliella
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years
- Fibrate treatment (for at least 6 weeks)
- HDL-Cholesterol lower than 40mg/dl.
- Triglyceride over 150mg/dl.
Who cannot join
- High CPK.
- Elevated liver functions.
- Active CHD.
- Smokers.
- Diabetes patients treated with Insulin or Avandia. HbA1C great than 8.5.
About this study
Official title: The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid
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
- Being tested
- Dunaliella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DunaliellaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2001
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low HDL CholesterolStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Ayelet Harari, Phd, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156169
- Sponsor's protocol ID
- SHEBA-01-2358-AH-CTIL
- Status last verified
- Aug 2009
- First submitted
- 8 Sep 2005
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Alga Dunaliella Bardawil as a Source of 9-cis Retinoic Acid
- ClinicalTrials.gov ID
- NCT00156169
- Acronym / sponsor ID
- SHEBA-01-2358-AH-CTIL
- Conditions
- Low HDL Cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2001
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-70 years
- Fibrate treatment (for at least 6 weeks)
- HDL-Cholesterol lower than 40mg/dl.
- Triglyceride over 150mg/dl.
Key exclusion criteria (5 listed)
- High CPK.
- Elevated liver functions.
- Active CHD.
- Smokers.
- Diabetes patients treated with Insulin or Avandia. HbA1C great than 8.5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dunaliella | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2009.
Related trials for Low HDL Cholesterol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayelet Harari, Phd study director
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dunaliella in people with Low HDL Cholesterol, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2009.