Metabolic Disease Clinical Trial
— LaFlavonOfficial 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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Lebanon | Rafic Hariri University Hospital | Beirut |
Lead Sponsor | Collaborator |
---|---|
Omicron Pharmaceuticals |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase in High-Density Lipoprotein (HDL) | Change from Baseline in High-Density Lipoprotein (HDL) at 3 months | Yes | |
Secondary | changes of liver enzymes | Baseline and 3 months | Yes |
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