Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.

Official Title
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Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study

Conditions
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Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Dietary Supplement: Viusid
* Other: Hypocaloric Diet with controlled exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis) Age between 18 and 70 years Ability to provide informed consent Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g) Exclusion Criteria: Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency) Pregnancy or lactation Decompensated cirrhosis Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter) Contraindication to liver biopsy Refusal to participate in the study Concomitant disease with reduced life expectancy Severe psychiatric conditions Drug dependence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Viusid, a nutritional supplement, in combination with controlled diet and exercise | Dietary Supplement: Viusid<br>* Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks<br>* Other names: Nutritional supplement;|
| Active Comparator: B<br>Controlled diet and exercise | Other: Hypocaloric Diet with controlled exercise<br>* Modified ADA diet in combination with controlled exercise daily 24 weeks<br>* Other names: lifestyle modification;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment). |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment) |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Nonalcoholic steatohepatitis, Nonalcoholic Fatty Liver, Nutritional supplement, Exercise