The Effects of Dihydromiricetin on MASLD

National and Kapodistrian University of Athens

Status: Completed

Conditions: NAFLD

Treatments: Dietary Supplement: Dihydromiricetin, Vitamin C, E and Choline; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05052515

436/14-06-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Oral treatment Two capsules twice daily for one year

Treatment:

Other: Placebo

Nutritional Supplementation

Experimental group

Description:

Oral treatment Two capsules twice daily for one year

Treatment:

Dietary Supplement: Dihydromiricetin, Vitamin C, E and Choline