The Effects of Natural Extracts Supplementation on NASH Patients

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05052515
• Other study ID #: 436/14-06-21
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: University of Athens
• Contact: Georgios Papatheodoridis, MD PhD
• Phone: +30 213 206 1115
• Email: gepapath[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Alanine aminotransferase (ALT) >1.5 times the greater normal value with or without elevated ?-glutamyl transpeptidase (?GT)

• 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 a systemic disease with potentially hepatic involvement

Related Conditions & MeSH terms

• NAFLD

Intervention

Dietary Supplement:
• Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts
Patients with NAFLD will be randomly allocated to receive Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts supplementation

Other:
• Placebo
Patients with NAFLD will be randomly allocated to receive placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Athens	Laik? General Hospital, Athens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Normalization of ALT and ?GT		6 and 12 months
Secondary	Improvement of Liver stiffness	Improvement of liver stiffness at liver elastography by > 1 kPa	12 months
Secondary	Improvement of FIB-4 score		6 and 12 months
Secondary	Improvement of NAFLD Fibrosis score		6 and 12 months