- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286909
Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL) (LaFlavon)
February 9, 2011 updated by: Omicron Pharmaceuticals
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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dr. Akram Echtay, M.D.
- Phone Number: +9613856323
Study Contact Backup
- Name: Sanan Sdepanian
- Phone Number: +9617098618
- Email: sanan_sdepanian@yahoo.com
Study Locations
-
-
-
Beirut, Lebanon
- Recruiting
- Rafic Hariri University Hospital
-
Contact:
- Dr. Akram Echtaye, M.D.
-
Principal Investigator:
- Dr. Akram Echtaye, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
- Known milk, soy or whey allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Placebo
|
|
Experimental: LaFlavon
|
two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in High-Density Lipoprotein (HDL)
Time Frame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
|
Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes of liver enzymes
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Akram Echtay, M.D., Rafic Hariri University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
January 9, 2011
First Submitted That Met QC Criteria
January 28, 2011
First Posted (Estimate)
January 31, 2011
Study Record Updates
Last Update Posted (Estimate)
February 10, 2011
Last Update Submitted That Met QC Criteria
February 9, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OP912011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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