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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Omicron Pharmaceuticals.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Omicron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01286909

First received: January 9, 2011

Last updated: February 9, 2011

Last verified: February 2011

History of Changes

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Metabolic Disorders Metabolic Syndrome

Drug Information available for: Lycopene

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

changes of liver enzymes [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]

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

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286909

Contacts

Contact: Dr. Akram Echtay, M.D.	+9613856323
Contact: Sanan Sdepanian	+9617098618	sanan_sdepanian@yahoo.com

Locations

Lebanon
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

Investigators

Principal Investigator:

Dr. Akram Echtay, M.D.

Rafic Hariri University Hospital

More Information

No publications provided

Responsible Party:	Dr. Akram Echtay, Omicron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01286909 History of Changes
Other Study ID Numbers:	OP912011
Study First Received:	January 9, 2011
Last Updated:	February 9, 2011
Health Authority:	United States: Food and Drug Administration Lebanon: Institutional Review Board

Keywords provided by Omicron Pharmaceuticals:

Metabolic

Additional relevant MeSH terms:

Metabolic Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents

Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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