Skip to main content
OpenTrials
Completed

NCT Number: NCT05052515

The Effects of Dihydromiricetin on MASLD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Athens "Laiko"

Athens, Attica, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dihydromiricetin, Vitamin C, E and Choline

Dietary Supplement

Patients with MASLD will be randomly allocated to receive capsules with Dihydromiricetin, Vitamin C, E and Choline

Placebo

Other

Patients with MASLD will be randomly allocated to receive placebo capsules

Primary outcomes

  1. ALT change

    Time frame: 12 months.

    ALT normalization or reduction of ALT >50% compared to baseline

Secondary outcomes

  1. ALT and GGT changes

    Time frame: 6 and 12 months

    Normalization of both ALT and GGT

  2. Liver stiffness change

    Time frame: 12 months

    Change of liver stiffness at liver elastography by >1 kPa

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

The Effects of Natural Extract With Dihydromiricetin on MASLD Patients

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 22, 2021
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.