Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis

Overview

Non-alcoholic steatohepatitis represents 10 – 15% total cases of hepatic cirrhosis. In the upcoming years, the economic burden of this disease will increase and will mean an important problem for our health system due to obesity epidemic. There are several treatments for non-alcoholic steatohepatitis; however, none of them have overcome a healthy lifestyle including diet, exercise and some drugs related with insulin metabolism. There after, using hepatoprotective drugs and antioxidants have been recommended as an eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis. Being this approach not only an experimental item yet but also an unavoidable reality. The purpose of this randomized controlled study is explore the effects of siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic parameters.

Full Title of Study: “Biochemical and Echosonographic Impacts Using Siliphos-Selenium-Methionine-Alpha Lipoic Acid + Metformin Versus Metformin in Patients With Fatty Liver and Steatohepatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2014

Interventions

  • Drug: Metformin
    • Patients with Steatohepatitis treated with diet, exercise and metformin
  • Dietary Supplement: Siliphos+ Selenium – Methionine + Alpha Lipoic Acid
    • Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) – Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
  • Dietary Supplement: Siliphos+ Selenium – Methionine + Alpha Lipoic Acid
    • Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) – Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
  • Drug: Metformin
    • Patients with fatty liver treated with diet, exercise and metformin

Arms, Groups and Cohorts

  • Active Comparator: Metformin
    • Patients treated with diet, exercise and metformin
  • Active Comparator: Suplement
    • Patients treated with diet, exercise and metformin plus Siliphos (140mg) + Selenium (15mcg) -Methionine 3mg + Alpha Lipoic Acid (200mg).

Clinical Trial Outcome Measures

Primary Measures

  • Impact on biochemical and echosonographic parameters
    • Time Frame: 6 months
    • Identify and measure if patients with metabolic syndrome with NALFD under Siliphos (140mg) + Selenium (15mcg) – Methionine (3mg) + Alfa lipoic acid (200mg) treatment added to conventional therapy improves echosonographic pattern measure accord bright scale and biochemical parameters like LFT´s compared with conventional therapy alone (metformin + diet + exercise).

Secondary Measures

  • Identify changes in anthropometric parameters
    • Time Frame: 6 months
    • Identify and measure changes in anthropometrics parameters of metabolic syndrome like BMI, fasting glucose, lipid profile, arterial pressure, abdominal perimeter, waist index.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with Metabolic Syndrome according to ATP III Criteria – Non smokers – Without intake of vitamins or herbal medicine for at least one month – Without uncontrolled glycemic levels – Compatible ultrasound and/or histological report Exclusion Criteria:

  • Alcohol ingest > 50 gr weekly or chronic alcoholism – Creatine serum > 2 mg/dL – Potassium serum > 5.5 mEq/L – Allergic to metformin or any components of the study – Pregnancy – Anomalies of blood coagulation or liver anatomic – Patients with diseases and/or treatment that cause fatty liver or steatohepatitis – Body weight change > 10% in the last 5 weeks

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Provider of Information About this Clinical Study
    • Principal Investigator: ALDO TORRE DELGADILLO, M.D. Science Master – Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Overall Official(s)
    • Aldo Torre Delgadillo, M.D., M. Sc., Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.