The Effects of Dihydromiricetin on MASLD

NCT ID: NCT05052515

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-06-30

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.

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Oral treatment Two capsules twice daily for one year

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients with MASLD will be randomly allocated to receive placebo capsules

Nutritional Supplementation

Oral treatment Two capsules twice daily for one year

Group Type: EXPERIMENTAL

Dihydromiricetin, Vitamin C, E and Choline

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Dihydromiricetin, Vitamin C, E and Choline

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Patients with MASLD will be randomly allocated to receive placebo capsules

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Georgios Papatheodoridis

Professor in Medicine & Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Papatheodoridis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

General Hospital of Athens "Laiko"

Athens, Attica, Greece

Countries

Greece

Other Identifiers

436/14-06-21

Identifier Type: -

Identifier Source: org_study_id