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
  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:


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:

  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
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 April 21, 2014