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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01286909 |
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Date of registration:
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09/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
LaFlavon |
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Scientific title:
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Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL) |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01286909 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Dr. Akram Echtaye, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dr. Akram Echtay, M.D. |
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Address:
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Telephone:
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+9613856323 |
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Email:
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Affiliation:
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Name:
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Dr. Akram Echtay, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rafic Hariri University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Men and Women with Metabolic Syndrome
2. Elevated Triglycerides (> 150)
3. Low High-Density Lipoprotein (HDL) (< 35)
4. Willingness to take study nutritional supplement once a day for 3 months
Exclusion Criteria:
1. Women who are pregnant, nursing, or who intend pregnancy during the period of
treatment
2. Known milk, soy or whey allergy
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metabolic Disease
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Intervention(s)
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Dietary Supplement: LaFlavon
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Primary Outcome(s)
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Increase in High-Density Lipoprotein (HDL)
[Time Frame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months]
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Secondary Outcome(s)
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changes of liver enzymes
[Time Frame: Baseline and 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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