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

Primary Purpose

Metabolic Disease

Status
Unknown status
Phase
Phase 3
Locations
Lebanon
Study Type
Interventional
Intervention
LaFlavon
Sponsored by
Omicron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Disease focused on measuring Metabolic

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rafic Hariri University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LaFlavon

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Increase in High-Density Lipoprotein (HDL)

Secondary Outcome Measures

changes of liver enzymes

Full Information

First Posted
January 9, 2011
Last Updated
February 9, 2011
Sponsor
Omicron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01286909
Brief Title
Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
Acronym
LaFlavon
Official Title
Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Omicron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease
Keywords
Metabolic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LaFlavon
Arm Type
Experimental
Arm Title
Placebo
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
LaFlavon
Other Intervention Name(s)
Lycopene/Isoflavon
Intervention Description
two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months
Primary Outcome Measure Information:
Title
Increase in High-Density Lipoprotein (HDL)
Time Frame
Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
Secondary Outcome Measure Information:
Title
changes of liver enzymes
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and Women with Metabolic Syndrome Elevated Triglycerides (> 150) Low High-Density Lipoprotein (HDL) (< 35) Willingness to take study nutritional supplement once a day for 3 months Exclusion Criteria: Women who are pregnant, nursing, or who intend pregnancy during the period of treatment Known milk, soy or whey allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Akram Echtay, M.D.
Phone
+9613856323
First Name & Middle Initial & Last Name or Official Title & Degree
Sanan Sdepanian
Phone
+9617098618
Email
sanan_sdepanian@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Akram Echtay, M.D.
Organizational Affiliation
Rafic Hariri University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rafic Hariri University Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Akram Echtaye, M.D.
First Name & Middle Initial & Last Name & Degree
Dr. Akram Echtaye, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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