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

February 9, 2011 updated by: Omicron Pharmaceuticals

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Akram Echtay, M.D.
  • Phone Number: +9613856323

Study Contact Backup

Study Locations

      • Beirut, Lebanon
        • Recruiting
        • Rafic Hariri University Hospital
        • Contact:
          • Dr. Akram Echtaye, M.D.
        • Principal Investigator:
          • Dr. Akram Echtaye, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Placebo
Experimental: LaFlavon
two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months
Other Names:
  • Lycopene/Isoflavon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in High-Density Lipoprotein (HDL)
Time Frame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months
Change from Baseline in High-Density Lipoprotein (HDL) at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
changes of liver enzymes
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr. Akram Echtay, M.D., Rafic Hariri University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

January 9, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

February 10, 2011

Last Update Submitted That Met QC Criteria

February 9, 2011

Last Verified

February 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Disease

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