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

Omicron Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Metabolic Disease

Treatments: Dietary Supplement: LaFlavon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01286909

OP912011

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

LaFlavon

Experimental group

Treatment:

Dietary Supplement: LaFlavon

Placebo

No Intervention group