Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)
Status:
Recruiting
Trial end date:
2024-02-28
Target enrollment:
Participant gender:
Summary
This is a 4-arm, prospective, randomized, double-blind, double-dummy, and placebo-controlled
clinical study comparing Proliverenol at a dose of 500 mg twice daily; Proliverenol at a dose
of 1000 mg once daily; Proliverenol at a dose of 1000 mg twice daily; and Placebo two caplets
daily for a 12-week course of therapy.
Proliverenol is a bioactive fraction derived from the dried fruit of Phaleria macrocarpa
(Scheff.) Boerl (Thymelaeaceae). Proliverenol possesses a hepatoprotective activity via
anti-inflammation, DNA repairing, and the antiapoptosis properties. Pre-clinical study of
Proliverenol showed that it exerted the hepatoprotective activity through increasing cell
survival via: 1) up-regulation of DNA repair enzyme; 2) down-regulation of NF-kB, TNFα and
caspase-8 expressions, to prevent ALT leakage in HepG2 cells. Proliverenol repressed ALT
expression, which could also be significantly important as possible alternative mechanism for
increased blood transaminase activities. Caspase-8 pathway seemed to be involved in the
molecular pathway rather than directly inducing mitochondrial damage. Taken together, ethanol
induced apoptosis through NF-kB-TNFα-caspase-8 pathway, and Proliverenol protected the cells
from the toxicity conditions.