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

NCT ID: NCT01286909

Last Updated: 2011-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LaFlavon

Group Type EXPERIMENTAL

LaFlavon

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LaFlavon

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lycopene/Isoflavon

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Omicron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omicron Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Akram Echtay, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rafic Hariri University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rafic Hariri University Hospital

Beirut, , Lebanon

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Lebanon

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dr. Akram Echtay, M.D.

Role: CONTACT

+9613856323

Sanan Sdepanian

Role: CONTACT

+9617098618

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Akram Echtaye, M.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OP912011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

DLBS1449 in Diabetic Patients With Low HDL
NCT01972477 WITHDRAWN PHASE2/PHASE3