The Effects of Dihydromiricetin on MASLD

NCT05052515 | Completed

• 1 other identifier: 436/14-06-21
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD

Keywords

dihydromiricetin

Outcome Measures

Primary Outcomes (1)

• ALT change

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

  12 months.

Secondary Outcomes (2)

• ALT and GGT changes

  6 and 12 months

• Liver stiffness change

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Oral treatment Two capsules twice daily for one year

Other: Placebo

Nutritional Supplementation

EXPERIMENTAL

Oral treatment Two capsules twice daily for one year

Dietary Supplement: Dihydromiricetin, Vitamin C, E and Choline

Interventions

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

Nutritional Supplementation

Placebo OTHER

Patients with MASLD will be randomly allocated to receive placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

General Hospital of Athens "Laiko"

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Ascorbic Acid; Choline

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Ethanolamines; Amino Alcohols; Alcohols; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Georgios Papatheodoridis, MD PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medicine & Gastroenterology

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: November 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)