Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)

Phase 3

• Conditions: Metabolic Disease
• Interventions: Dietary Supplement: LaFlavon

• Registration Number: NCT01286909
• Lead Sponsor: Omicron Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-09
• Study First Submitted QC: 2011-01-28
• Study First Posted: 2011-01-31
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-10
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LaFlavon	LaFlavon	-

Primary Outcome Measures

Name	Time	Method
Increase in High-Density Lipoprotein (HDL)	Change from Baseline in High-Density Lipoprotein (HDL) at 3 months

Secondary Outcome Measures

Name	Time	Method
changes of liver enzymes	Baseline and 3 months

Trial Locations

Locations (1)

Rafic Hariri University Hospital; 🇱🇧 Beirut, Lebanon