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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01286909
Other study ID # OP912011
Secondary ID
Status Recruiting
Phase Phase 3
First received January 9, 2011
Last updated February 9, 2011
Start date January 2011
Est. completion date June 2011

Study information

Verified date February 2011
Source Omicron Pharmaceuticals
Contact Dr. Akram Echtay, M.D.
Phone +9613856323
Is FDA regulated No
Health authority United States: Food and Drug AdministrationLebanon: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
LaFlavon
two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months

Locations

Country Name City State
Lebanon Rafic Hariri University Hospital Beirut

Sponsors (1)

Lead Sponsor Collaborator
Omicron Pharmaceuticals

Country where clinical trial is conducted

Lebanon, 

Outcome

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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