The Effects of Dihydromiricetin on MASLD

NCT05052515 — Not applicable, Completed, 55 participants, University of Athens

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

The Effects of Natural Extract With Dihydromiricetin on MASLD Patients

Registry	NCT05052515
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	55 (Actual)
Sponsor	University of Athens (Other)
Conditions	NAFLD
Interventions	Dihydromiricetin, Vitamin C, E and Choline, Placebo (Dietary supplement, other)
Dates	start 2021-11-01, primary completion 2023-06-30, completion 2024-06-30, first posted 2021-09-22, last updated 2025-05-21
Locations	1 site in Greece

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Other: Placebo	Oral treatment Two capsules twice daily for one year
Nutritional Supplementation	Experimental	Dietary Supplement: Dihydromiricetin, Vitamin C, E and Choline	Oral treatment Two capsules twice daily for one year

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

+Outcome measures

Primary outcomes

ALT change [12 months.]: ALT normalization or reduction of ALT >50% compared to baseline

Secondary outcomes

ALT and GGT changes [6 and 12 months]: Normalization of both ALT and GGT
Liver stiffness change [12 months]: Change of liver stiffness at liver elastography by >1 kPa

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
General Hospital of Athens "Laiko"	Athens, Attica	Greece

+Investigators

Georgios Papatheodoridis, MD PhD, Principal investigator, National and Kapodistrian University of Athens