The Effects of Dihydromiricetin on MASLD

Not Applicable

Completed

• Conditions: NAFLD
• Interventions: Dietary Supplement: Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts; Other: Placebo

• Registration Number: NCT05052515
• Lead Sponsor: University of Athens

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, whereas dihydromiricetin natural extracts have been suggested to exhibit antioxidant activity. In contrast to Vitamin E, which has been studied as an agent for non-diabetic patients with NAFLD, epidemiological and/or clinical data for the use of dihydromiricetin 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 systemic errors, such as selection bias and the placebo effect. Patients will be randomly assigned to one of two groups: A) capsules with dihydromiricetin, vitamins C/E and choline (two capsules per day) and B) placebo (identical capsules). The duration of the intervention will be 12 months.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Study Start: 2021-11-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Alanine aminotransferase (ALT) higher than the upper limit of normal with or without elevated γ-glutamyl transpeptidase (γGT)
• Hepatic steatosis-indicating findings on ultrasound and / or liver biopsy
• BMI 20-45 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Supplementation	Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts	Oral treatment Two tablets twice a day for one year
Placebo	Placebo	Oral treatment Two tablets twice a day for one year

Primary Outcome Measures

Name	Time	Method
ALT change	12 months.	ALT normalization or reduction of ALT \>50% compared to baseline

Secondary Outcome Measures

Name	Time	Method
ALT and GGT changes	6 and 12 months	Normalization of both ALT and GGT
Liver stiffness change	12 months	Change of liver stiffness at liver elastography by \>1 kPa

Trial Locations

Locations (1)

General Hospital of Athens "Laiko"; 🇬🇷 Athens, Attica, Greece