A Phase 2 interventional study of Palm Tocotrienol Rich Fraction (TRF) and Refined, bleached, and deodorised (RBD) palm olein in Alcoholic Fatty Liver Disease, sponsored by Universiti Kebangsaan Malaysia Medical Centre. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Universiti Kebangsaan Malaysia Medical Centre · Phase 2, Interventional, and Treatment
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.
Recent evidence from preclinical studies has shown that tocotrienols, a unique form of Vitamin E derived from palm oil, possess strong antioxidant, anti-inflammatory, and hepatoprotective properties. These effects have been demonstrated in non-alcoholic fatty liver disease (NAFLD) models, suggesting their potential benefit in alcohol-related liver injury as well. However, clinical evidence in human AFLD populations remains limited. Therefore, this study seeks to investigate the efficacy and safety of palm tocotrienol-rich fraction supplementation in patients with AFLD.
This is a randomized, double-blind, placebo-controlled Phase II clinical trial involving 26 adult participants aged 18 to 65 years who have been clinically diagnosed with alcoholic fatty liver disease. Participants will be randomly assigned to either: Treatment group (n = 13): receiving palm tocotrienol-rich fraction soft gels (200 mg twice daily); or Placebo group (n = 13): receiving refined, bleached, and deodorised (RBD) palm olein soft gels (200 mg twice daily). The intervention period will last six months, with follow-up assessments every three months. Participants will complete structured questionnaires on alcohol consumption patterns, lifestyle, and dietary habits at each visit. Blood samples will be collected at baseline and follow-up visits to evaluate liver function tests (ALT, AST, GGT, ALP, bilirubin), oxidative stress markers, haematological parameters, and inflammatory biomarkers such as cytokines. Non-invasive liver assessments, including FibroScan and FibroTest, will be performed twice during the study to monitor changes in liver fat content, and stiffness levels.
This study aims to provide scientific evidence on the efficacy of tocotrienol-rich fraction in improving liver health among individuals with AFLD. If proven effective, tocotrienol may represent a safe therapeutic option for mitigating alcohol-induced liver injury. The findings will also contribute to the development of evidence-based nutraceutical applications of palm tocotrienol and support efforts to diversify and add value to Malaysia's palm oil industry through health-promoting innovations. Moreover, the results will serve as baseline data for larger-scale clinical trials and future research into tocotrienol's broader therapeutic potential.
824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.
This study's planned enrollment of 26 is below the median of 52 across 521 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Universiti Kebangsaan Malaysia Medical Centre is the lead sponsor of 58 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with other concomitant liver diseases:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment group will be prescribed with palm tocotrienol soft gel capsules (200 mg twice daily) for six months
Dietary Supplement: Palm Tocotrienol Rich Fraction (TRF)
The placebo group will receive refined, bleached, and deodorised (RBD) palm olein for six months.
Other: Refined, bleached, and deodorised (RBD) palm olein
The 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.
The 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.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
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.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention.
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.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention.
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.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Between-group difference in ALT at 3 and 6 months (TRF vs placebo)
Measured in units per liter (U/L); Lower values indicate improvement.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Between-group difference in GGT at 3 and 6 months (TRF vs placebo)
Measured in units per liter (U/L); Lower values indicate improvement.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Change from baseline in Fatty Liver Index (FLI) at 3 and 6 months
Unitless score (range 0-100); Reported as absolute and percentage change; Higher scores indicate greater hepatic steatosis (worse outcome).
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Between-group difference in Fatty Liver Index (FLI) at 3 and 6 months (TRF vs placebo).
Range 0-100; Higher scores indicate worse steatosis.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Change from baseline in Liver Stiffness Measurement using Transient Elastography (FibroScan® score) at 3 and 6 months
Measured in kilopascals (kPa; typical range 2-75); Reported as absolute and percentage change; Higher values indicate greater fibrosis (worse outcome).
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Between-group difference in Liver Stiffness Measurement (FibroScan® score) at 3 and 6 months (TRF vs placebo)
Measured in kilopascals (kPa; typical range 2-75); Higher values indicate worse fibrosis.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
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)
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
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.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
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
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
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
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Concentration at 3 and 6 months
Measured in milligrams per deciliter (mg/dL); Typical ranges: 40-60 mg/dL; Higher HDL-C reflects a better metabolic profile.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Change From Baseline in Triglyceride (TG) Concentration at 3 and 6 months.
Measured in milligrams per deciliter (mg/dL); Typical ranges: 0-150 mg/dL; Higher triglycerides reflect a worse metabolic profile
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Plan to share: Yes — All IPD that underlie results in a publication
Start is estimated for May 2026; primary completion for Nov 2026, 6 months later.
Of 41 phase 2 interventional studies under Liver Diseases, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Universiti Kebangsaan Malaysia Medical Centre