NAFLD
Conditions
Keywords
dihydromiricetin
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.
Interventions
DIETARY_SUPPLEMENTDihydromiricetin, Vitamin C, E and Choline
Patients with MASLD will be randomly allocated to receive capsules with Dihydromiricetin, Vitamin C, E and Choline
OTHERPlacebo
Patients with MASLD will be randomly allocated to receive placebo capsules
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALT change | 12 months. | ALT normalization or reduction of ALT \>50% compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Outcome results
None listed