Metabolic DiseasePhase 3LaFlavonNCT01286909
Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
A Phase 3 study testing LaFlavon in people with Metabolic Disease, run by Omicron Pharmaceuticals at 1 site in Lebanon.
Trial summary
A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- LaFlavon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLebanon
- Study dates
- Jan 2011to Jun 2011
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women with Metabolic Syndrome
- Elevated Triglycerides (> 150)
- Low High-Density Lipoprotein (HDL) (< 35)
- Willingness to take study nutritional supplement once a day for 3 months
Who cannot join
- Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
- Known milk, soy or whey allergy
Trial locations and contacts
1 site in 1 country.
Dr. Akram Echtay, M.D. contact
Lebanon1 site, 1 recruiting
- Recruiting
Rafic Hariri University Hospital
Beirut
Dr. Akram Echtaye, M.D.
Dr. Akram Echtaye, M.D.
About this study
Official title: Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).
- Conditions
- Metabolic Disease
- Being tested
- LaFlavon
- Keywords
- Metabolic
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaFlavonDietary supplement
Also called Lycopene/Isoflavon
two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months
| Study group | Role | What they receive |
|---|---|---|
| LaFlavon | Experimental | Not described Receives: Dietary Supplement: LaFlavon |
| Placebo | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in High-Density Lipoprotein (HDL)
Measured: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
Secondary outcomes (1)
changes of liver enzymes
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omicron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Akram Echtay, M.D., Principal investigator, Rafic Hariri University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286909
- Sponsor's protocol ID
- OP912011
- Acronym
- LaFlavon
- Status last verified
- Feb 2011
- First submitted
- 9 Jan 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
- ClinicalTrials.gov ID
- NCT01286909
- Acronym / sponsor ID
- LaFlavon / OP912011
- Conditions
- Metabolic Disease
- Keywords
- Metabolic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Omicron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 31 Jan 2011 (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.
A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LaFlavon | Experimental | Dietary Supplement: LaFlavon |
| Placebo | No intervention | – |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and Women with Metabolic Syndrome
- Elevated Triglycerides (> 150)
- Low High-Density Lipoprotein (HDL) (< 35)
- Willingness to take study nutritional supplement once a day for 3 months
Key exclusion criteria (2 listed)
- Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
- Known milk, soy or whey allergy
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 |
|---|---|---|
| LaFlavonAlso: Lycopene/Isoflavontwo tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months | Dietary supplement | LaFlavon |
Primary outcome
Increase in High-Density Lipoprotein (HDL)
Time frame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
1 secondary outcome
changes of liver enzymes
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
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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.
Dr. Akram Echtay, M.D. contact
Dr. Akram Echtay, M.D. principal investigator
Rafic Hariri University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LaFlavon in people with Metabolic Disease, run by Omicron Pharmaceuticals at 1 site in Lebanon.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Akram Echtay, M.D. (+9613856323), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in High-Density Lipoprotein (HDL) (time frame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months). It is what the study was designed to measure, not a finding.
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 10 Feb 2011.