The Effects of Natural Extracts Supplementation on NASH Patients

Study Overview
=================
Brief Summary
-----------------
The global wave of obesity has affected dramatically the incidence of non-alcoholic fatty liver disease (NAFLD) making it the leading cause of liver disease in the western world. NAFLD is considered the hepatic manifestation of metabolic syndrome and is strongly associated with type II diabetes, sleep apnea and cardiovascular disease. Although cardiovascular disease is the leading cause of death in patients with NAFLD, a subset of patients who meet the histological criteria for steatohepatitis have the highest risk for liver-related morbidity and mortality. Reviewing literature, it appears that several pathophysiologic mechanisms related to metabolism, inflammation and fibrosis are deregulated in NAFLD. Choline, Vitamin C, Vitamin E and Ampelopsis Grossedentata natural extracts exhibit high antioxidant activity. In contrast to Vitamin E, which has been extensively studied and has a role as a drug of choice in non-diabetic patients with NAFLD, epidemiological or clinical data for the use of Choline, Vitamin C, Ampelopsis Grossedentata natural extracts or their combination in NAFLD are limited.

Detailed Description
-----------------
The study will be randomized, placebo-controlled and double-blinded in order to avoid a number of systemic errors, such as selection bias and the placebo effect. Patients will be randomly assigned to one of the two categories: (A) a placebo group (B) a Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts tablets supplementation group (two tablets twice per day). The duration of the intervention will be 12 months.

Official Title
-----------------
The Effects of Choline,Vitamin C, Vitamin E and Ampelopsis Grossedentata Natural Extracts Supplementation on NASH Patients

Conditions
-----------------
NAFLD

Intervention / Treatment
-----------------
* Dietary Supplement: Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alanine aminotransferase (ALT) >1.5 times the greater normal value with or without elevated γ-glutamyl transpeptidase (γGT) Hepatic steatosis-indicating findings on ultrasound and / or liver biopsy BMI 20-40 Kg/m2 Exclusion Criteria: Alcohol consumption > 210 or > 140 grams per week for men or women, respectively Use of a potentially hepatotoxic drug Detection of hepatitis B virus (HBsAg) surface antigen or Hepatitis C virus antibodies (anti-HCV) or HIV antibodies The coexistence of α systemic disease with potentially hepatic involvement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oral treatment Two tablets twice a day for one year | Other: Placebo<br>* Patients with NAFLD will be randomly allocated to receive placebo<br>|
| Experimental: Nutritional Supplementation<br>Oral treatment Two tablets twice a day for one year | Dietary Supplement: Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts<br>* Patients with NAFLD will be randomly allocated to receive Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts supplementation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint | The primary endpoint will be the clinically beneficial reduction in ALT, defined as the return of ALT within normal limits or the reduction of ALT by> 50% of its baseline value. | It will be estimated at 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of ALT and γGT |  | 6 and 12 months | 
| Improvement of Liver stiffness | Improvement of liver stiffness at liver elastography by > 1 kPa | 12 months | 
| Improvement of FIB-4 score |  | 6 and 12 months | 
| Improvement of NAFLD Fibrosis score |  | 6 and 12 months |