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

Phase 4

Completed

• Conditions: Liver Disease
• Interventions: Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid; Drug: Metformin

• Registration Number: NCT01650181
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Impact on biochemical and echosonographic parameters	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 Outcome Measures

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

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico