The Effects of Dihydromiricetin on MASLD

The Effects of Natural Extract With Dihydromiricetin on MASLD Patients

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.

Study Overview

• Status: Completed
• Conditions: NAFLD
• Intervention / Treatment: Other: Placebo; Dietary supplement: Dihydromiricetin, Vitamin C, E and Choline

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Athens "Laiko"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oral treatment Two capsules twice daily for one year	Other: Placebo; Patients with MASLD will be randomly allocated to receive placebo capsules
Experimental: Nutritional Supplementation; Oral treatment Two capsules twice daily for one year	Dietary supplement: Dihydromiricetin, Vitamin C, E and Choline; Patients with MASLD will be randomly allocated to receive capsules with Dihydromiricetin, Vitamin C, E and Choline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALT change	ALT normalization or reduction of ALT >50% compared to baseline	12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALT and GGT changes	Normalization of both ALT and GGT	6 and 12 months
Liver stiffness change	Change of liver stiffness at liver elastography by >1 kPa	12 months

Collaborators and Investigators

• Sponsor: University of Athens
• Collaborators: Laikο General Hospital, Athens
• Investigators: Principal Investigator: Georgios Papatheodoridis, MD PhD, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: dihydromiricetin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antimetabolites; Nootropic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: 436/14-06-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No