NCT01286909

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 10, 2011

Status Verified

February 1, 2011

Enrollment Period

5 months

First QC Date

January 9, 2011

Last Update Submit

February 9, 2011

Conditions

Metabolic Disease

Keywords

Metabolic

Outcome Measures

Primary Outcomes (1)

  • Increase in High-Density Lipoprotein (HDL)

    Change from Baseline in High-Density Lipoprotein (HDL) at 3 months

Secondary Outcomes (1)

  • changes of liver enzymes

    Baseline and 3 months

Study Arms (2)

LaFlavon

EXPERIMENTAL
Dietary Supplement: LaFlavon

Placebo

NO INTERVENTION

Interventions

LaFlavonDIETARY_SUPPLEMENT

two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months

Also known as: Lycopene/Isoflavon
LaFlavon

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
  • Known milk, soy or whey allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafic Hariri University Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Dr. Akram Echtay, M.D.

    Rafic Hariri University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Akram Echtay, M.D.

CONTACT

+9613856323

Sanan Sdepanian

CONTACT

+9617098618sanan_sdepanian@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2011

First Posted

January 31, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 10, 2011

Record last verified: 2011-02

Locations

LE(1)