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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 4

Conditions: Liver Disease

Treatments: Drug: Metformin; Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01650181

GAS-399-11/11/1

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Metformin

Active Comparator group

Description:

Patients treated with diet, exercise and metformin

Treatment:

Drug: Metformin

Drug: Metformin

Suplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid

Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid