This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Omicron Pharmaceuticals.
Recruitment status was:  Recruiting
Information provided by:
Omicron Pharmaceuticals Identifier:
First received: January 9, 2011
Last updated: February 9, 2011
Last verified: February 2011
A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).

Condition Intervention Phase
Metabolic Disease Dietary Supplement: LaFlavon Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Laflavon in Patients With Metabolic Syndrome to Evaluate Its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)

Resource links provided by NLM:

Further study details as provided by Omicron Pharmaceuticals:

Primary Outcome Measures:
  • Increase in High-Density Lipoprotein (HDL) [ Time Frame: Change from Baseline in High-Density Lipoprotein (HDL) at 3 months ]

Secondary Outcome Measures:
  • changes of liver enzymes [ Time Frame: Baseline and 3 months ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LaFlavon Dietary Supplement: LaFlavon
two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months
Other Name: Lycopene/Isoflavon
No Intervention: Placebo


Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01286909

Contact: Dr. Akram Echtay, M.D. +9613856323
Contact: Sanan Sdepanian +9617098618

Rafic Hariri University Hospital Recruiting
Beirut, Lebanon
Contact: Dr. Akram Echtaye, M.D.         
Principal Investigator: Dr. Akram Echtaye, M.D.         
Sponsors and Collaborators
Omicron Pharmaceuticals
Principal Investigator: Dr. Akram Echtay, M.D. Rafic Hariri University Hospital
  More Information

Responsible Party: Dr. Akram Echtay, Omicron Pharmaceuticals Identifier: NCT01286909     History of Changes
Other Study ID Numbers: OP912011
Study First Received: January 9, 2011
Last Updated: February 9, 2011

Keywords provided by Omicron Pharmaceuticals:

Additional relevant MeSH terms:
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents processed this record on August 23, 2017