Efficacy of Laflavon in Lowering Triglycerides and Raisin... | NCT01286909

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

NCT01286909

Sponsor

Omicron Pharmaceuticals

Status

Unknown status

Last Update Posted

Feb 10, 2011Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Metabolic Disease

Interventions

LaFlavon

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Jan 9, 2011

First Submission Date that Met QC Criteria

Jan 28, 2011

First Posted Date

Jan 31, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2011

Last Update Posted Date

Feb 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LaFlavon	Experimental		Dietary Supplement: LaFlavon
Placebo	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LaFlavon	Dietary Supplement	two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months	LaFlavon

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
changes of liver enzymes		Baseline and 3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Akram Echtay, M.D.	Contact	+9613856323
Sanan Sdepanian	Contact	+9617098618		sanan_sdepanian@yahoo.com

Overall Officials

Name	Affiliation	Role
Dr. Akram Echtay, M.D.	Rafic Hariri University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rafic Hariri University Hospital	Recruiting	Beirut			Lebanon

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077276	Lycopene

Ancestor Terms

ID	Term
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided