This clinical study aims to explore the potential liver-protective effects of palm tocotrienol-rich fraction (a form of Vitamin E) in adults with alcoholic fatty liver disease (AFLD). A total of 26 participants aged 18 to 65 years with AFLD will be randomly assigned to receive either tocotrienol (200 mg twice daily) or a placebo for six months. Throughout the study, participants will undergo regular liver health assessments including blood tests, FibroScan, and FibroTest, alongside evaluations of oxidative stress and inflammation markers. The study aims to determine whether tocotrienol can help improve liver function and reduce alcohol-related liver damage. Findings from this trial may provide valuable evidence for future clinical studies and highlight the potential of Malaysian palm-based tocotrienol as a natural, supportive approach to liver health.
Patients with history of alcoholic use disorder with clinical and biochemical evidence of alcoholic steatohepatitis (AST:ALT >2.0, elevated GGT)
Patients with Maddrey's discriminant function ≤ 32, and do not require the treatment of corticosteroid therapy or pentoxifylline.
Patients aged 18 to 65
Patients who could comply with alcohol abstinence.
Severe alcoholic hepatitis defined as Maddrey's discriminant function >32
Hepatitis B
Hepatitis C
Non-alcoholic fatty liver disease (NAFLD)
Parallel
Palm Tocotrienol Rich Fraction (TRF)
Dietary supplementThe treatment group will be prescribed with palm tocotrienol soft gel (200 mg twice daily). The composition of the tocotrienol mixture is 24.7% α-tocotrienol, 4.5% β-tocotrienol, 36.9% γ-tocotrienol, 12.0% σ-tocotrienol and 21.6% α-tocopherol. It is formulated with a self-emulsifying system (SES) to enhance absorption of tocotrienol. One soft gel will be taken orally, daily after breakfast and dinner to complete the 400 mg daily dose. The treatment period will be 6 months.
Refined, bleached, and deodorised (RBD) palm olein
Other interventionThe placebo consisted of an equivalent volume of refined, bleached, and deodorised (RBD) palm olein. The placebo was formulated as soft gelatin capsules that were identical to the tocotrienol capsules in colour, size, shape, and surface texture.
Change from baseline in Aspartate Aminotransferase (AST) at 3 and 6 months
Reported as absolute and percentage change; Measured in units per liter (U/L); Typical range: 8-48 U/L; Lower values indicate improved liver function.
Change from baseline in Alanine Aminotransferase (ALT) at 3 and 6 months
Reported as absolute and percentage change; Measured in units per liter (U/L); Typical ranges: 7-56 U/L; Lower values indicate improved liver function.
Change from baseline in Gamma-Glutamyl Transferase (GGT) at 3 and 6 months
Reported as absolute and percentage change; Measured in units per liter (U/L); Typical ranges: 8 - 61 U/L; Lower values indicate improved liver function.
Between-group difference in AST at 3 and 6 months (Tocotrienol-Rich Fraction [TRF] vs placebo)
Measured in units per liter (U/L); Lower values indicate improvement.
Change From Baseline in Plasma Cytokine Levels (Anti-inflammatory Effect of Tocotrienols) at 3 and 6 months.
Cytokine measured: Interleukin-6 (IL-6) in plasma; Measurement method: Multiplex Enzyme-Linked Immunosorbent Assay (ELISA); Measured in picograms per milliliter (pg/mL); Normal range: \< 5-7 pg/mL; Higher values indicate greater inflammation (worse outcome)
Change From Baseline in Fasting Blood Glucose [FBG] Concentration at 3 and 6 months
Measured in milligrams per deciliter (mg/dL); Typical ranges: 70-100 mg/dL; Higher values indicate worse metabolic profile.
Change From Baseline in Total Cholesterol (TC) Concentration at 3 and 6 months
Measured in milligrams per deciliter (mg/dL); Typical ranges: 125-200 mg/dL; Higher total cholesterol reflect a worse metabolic profile
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration at 3 and 6 months
Measured in milligrams per deciliter (mg/dL); Typical ranges: 0-130 mg/dL; Higher LDL-C reflect a worse metabolic profile
Map coordinates are unavailable for these locations. Locations are shown below instead.
MalaysiaClick on the lead sponsor to view all of their trials.
Universiti Kebangsaan Malaysia Medical Centre
Lead sponsor
Malaysia Palm Oil Board
Collaborator
Hovid Berhad
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
