Alcoholic Fatty Liver DiseasePhase 2NCT07466485
The Efficacy of Tocotrienol Rich Fraction for Liver Protection in Adult Patients With Alcoholic Fatty Liver Disease (AFLD)
A Phase 2 study testing Palm Tocotrienol Rich Fraction (TRF) and Refined, bleached, and deodorised (RBD) palm olein in people with Alcoholic Fatty Liver Disease, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholic Fatty Liver Disease
- What is being tested?
- Palm Tocotrienol Rich Fraction (TRF) and Refined, bleached, and deodorised (RBD) palm olein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 May 2026to 15 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe alcoholic hepatitis defined as Maddrey's discriminant function >32
- Patients with other concomitant liver diseases:
- Hepatitis B
- Hepatitis C
- Non-alcoholic fatty liver disease (NAFLD)
- Autoimmune hepatitis (AIH)
Show all 21Show fewer
- Hereditary hemochromatosis
- Patients who are obese (a BMI of 30 kg/ m2 or more) and with metabolic syndromes
- Patients with bleeding disorders and who have been on anticoagulant or antiaggregant treatments
- Patients who have been on corticosteroid therapy or pentoxifylline for alcoholic hepatitis
- Patients with hepatocellular carcinoma
- Pregnant patients
- Patients who are breastfeeding
- Patients with Childs C liver cirrhosis
- Patients who have pyridoxine allergy or history
- Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc.
- Patients taking vitamin E, herbal supplements, or other investigational products within 90 days prior to the participation in the study.
- Patients who have been taken any medications that could affect the treatment: hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, long-term use of NSAIDs, statins, neuroleptics, anticonvulsant medications, high-dose acetaminophen(>=2.5g/day)
- Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
- Patients who could not comply with alcohol abstinence.
- Patient who considered ineligible for participation in the study as Investigator's judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak
Cheras, Kuala Lumpur, 56000
Siti Norain Azahar, Medicine (MD), 60-1126792792, drainazahar@gmail.com
About this study
Official title: The Effect of Palm Tocotrienol Rich Fraction on Alcoholic Fatty Liver Disease (AFLD): A Phase II Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Alcoholic Fatty Liver Disease
- Being tested
- Palm Tocotrienol Rich Fraction (TRF), Refined, bleached, and deodorised (RBD) palm olein
- Keywords
- Liver diseases, Tocotrienols, Antioxidants, Oxidative stress
- Medical subject headings
- Fatty Liver, Alcoholic, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm Tocotrienol Rich Fraction (TRF)Dietary supplement
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.
Refined, bleached, and deodorised (RBD) palm oleinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (mixed tocotrienol) | Active comparator | The treatment group will be prescribed with palm tocotrienol soft gel capsules (200 mg twice daily) for six months Receives: Dietary Supplement: Palm Tocotrienol Rich Fraction (TRF) |
| Placebo group | Placebo comparator | The placebo group will receive refined, bleached, and deodorised (RBD) palm olein for six months. Receives: Other: Refined, bleached, and deodorised (RBD) palm olein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From enrollment to the end of treatment at 3 and 6 months post intervention
Secondary outcomes (6)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start2 May 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomised, double-mask, placebo-controlled (parallel group), phase 2 clinical trial investigating the effect of palm tocotrienol-rich fraction on alcoholic fatty liver disease (AFLD).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Hovid Berhad
- Responsible party
- Sponsor
- Investigators
- Professor Dr. Nur Azlina Mohd Fahami, DVM, Principal investigator, Department of Pharmacology, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466485
- Sponsor's protocol ID
- JEP-2021-694
- Other IDs
- TAP-K010316
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
REFERENCES: 1. Liver EAftSot. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. Journal of hepatology 2018;69: 154-181. 2. Institute for Public Health (IPH), National Institutes of Health, Ministry of Health Malaysia. 2020. National Health and Morbidity Survey (NHMS) 2019: Vol. I: NCDs - NonCommunicable Diseases: Risk Factors and other Health Problems. 3. Chacko KR, Reinus J. Spectrum of alcoholic liver disease. Clinics in liver disease 2016;20: 419-427. 4. Deleuran T, Grønbaek H, Vilstrup H, Jepsen P. Cirrhosis and mortality risks of biopsy- verified alcoholic pure steatosis and steatohepatitis: a nationwide registry-based study. Alimentary pharmacology & therapeutics 2012;35: 1336-1342. 5. Setshedi M, Wands JR, de la Monte SM. Acetaldehyde adducts in alcoholic liver disease. Oxidative medicine and cellular longevity 2010;3. 6. Rolla R, Vay D, Mottaran E, et al. Detection of circulating antibodies against malondialdehyde-acetaldehyde adducts in patients with alcohol-induced liver disease. Hepatology 2000;31: 878-884. 7. Nagata K, Suzuki H, Sakaguchi S. Common pathogenic mechanism in development progression of liver injury caused by non-alcoholic or alcoholic steatohepatitis. J Toxicol Sci. 2007;32(5):453-68. 8. Nath B, Levin I, Csak T, Petrasek J, Mueller C, Kodys K, et al. Hepatocyte-specific hypoxia- inducible factor-1α is a determinant of lipid accumulation and liver injury in alcoholinduced steatosis in mice. Hepatology. 2011;53(5):1526-37. 9. Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, et al. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. (2012) 55:2005-23. 10. European Association for the Study of the Liver, European Association for the Study of Diabetes, European Association for the Study of Obesity. EASL-EASD-EA
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Palm Tocotrienol Rich Fraction on Alcoholic Fatty Liver Disease (AFLD): A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07466485
- Acronym / sponsor ID
- JEP-2021-694
- Conditions
- Alcoholic Fatty Liver Disease
- Keywords
- Liver diseases, Tocotrienols, Antioxidants, Oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Hovid Berhad
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomised, double-mask, placebo-controlled (parallel group), phase 2 clinical trial investigating the effect of palm tocotrienol-rich fraction on alcoholic fatty liver disease (AFLD).
| Arm | Type | Receives |
|---|---|---|
| Treatment group (mixed tocotrienol) | Active comparator | Dietary Supplement: Palm Tocotrienol Rich Fraction (TRF)The treatment group will be prescribed with palm tocotrienol soft gel capsules (200 mg twice daily) for six months |
| Placebo group | Placebo comparator | Other: Refined, bleached, and deodorised (RBD) palm oleinThe placebo group will receive refined, bleached, and deodorised (RBD) palm olein for six months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- Severe alcoholic hepatitis defined as Maddrey's discriminant function >32
- Patients with other concomitant liver diseases:
- Patients who are obese (a BMI of 30 kg/ m2 or more) and with metabolic syndromes
- Patients with bleeding disorders and who have been on anticoagulant or antiaggregant treatments
- Patients who have been on corticosteroid therapy or pentoxifylline for alcoholic hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palm Tocotrienol Rich Fraction (TRF)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. | Dietary supplement | Treatment group (mixed tocotrienol) |
| Refined, bleached, and deodorised (RBD) palm oleinThe 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. | Other | Placebo group |
Primary outcome
Change from baseline in Aspartate Aminotransferase (AST) at 3 and 6 months
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
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
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention.
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
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention.
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)
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Measured in units per liter (U/L); Lower values indicate improvement.
Between-group difference in ALT at 3 and 6 months (TRF vs placebo)
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Measured in units per liter (U/L); Lower values indicate improvement.
Between-group difference in GGT at 3 and 6 months (TRF vs placebo)
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Measured in units per liter (U/L); Lower values indicate improvement.
Change from baseline in Fatty Liver Index (FLI) at 3 and 6 months
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Unitless score (range 0-100); Reported as absolute and percentage change; Higher scores indicate greater hepatic steatosis (worse outcome).
Between-group difference in Fatty Liver Index (FLI) at 3 and 6 months (TRF vs placebo).
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Range 0-100; Higher scores indicate worse steatosis.
Change from baseline in Liver Stiffness Measurement using Transient Elastography (FibroScan® score) at 3 and 6 months
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Measured in kilopascals (kPa; typical range 2-75); Reported as absolute and percentage change; Higher values indicate greater fibrosis (worse outcome).
Between-group difference in Liver Stiffness Measurement (FibroScan® score) at 3 and 6 months (TRF vs placebo)
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Measured in kilopascals (kPa; typical range 2-75); Higher values indicate worse fibrosis.
6 secondary outcomes
Change From Baseline in Plasma Cytokine Levels (Anti-inflammatory Effect of Tocotrienols) at 3 and 6 months.
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
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
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
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
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.
Time frame: From enrollment to the end of treatment at 3 and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- BackgroundREFERENCES: 1. Liver EAftSot. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. Journal of hepatology 2018;69: 154-181. 2. Institute for Public Health (IPH), National Institutes of Health, Ministry of Health Malaysia. 2020. National Health and Morbidity Survey (NHMS) 2019: Vol. I: NCDs - NonCommunicable Diseases: Risk Factors and other Health Problems. 3. Chacko KR, Reinus J. Spectrum of alcoholic liver disease. Clinics in liver disease 2016;20: 419-427. 4. Deleuran T, Grønbaek H, Vilstrup H, Jepsen P. Cirrhosis and mortality risks of biopsy- verified alcoholic pure steatosis and steatohepatitis: a nationwide registry-based study. Alimentary pharmacology & therapeutics 2012;35: 1336-1342. 5. Setshedi M, Wands JR, de la Monte SM. Acetaldehyde adducts in alcoholic liver disease. Oxidative medicine and cellular longevity 2010;3. 6. Rolla R, Vay D, Mottaran E, et al. Detection of circulating antibodies against malondialdehyde-acetaldehyde adducts in patients with alcohol-induced liver disease. Hepatology 2000;31: 878-884. 7. Nagata K, Suzuki H, Sakaguchi S. Common pathogenic mechanism in development progression of liver injury caused by non-alcoholic or alcoholic steatohepatitis. J Toxicol Sci. 2007;32(5):453-68. 8. Nath B, Levin I, Csak T, Petrasek J, Mueller C, Kodys K, et al. Hepatocyte-specific hypoxia- inducible factor-1α is a determinant of lipid accumulation and liver injury in alcoholinduced steatosis in mice. Hepatology. 2011;53(5):1526-37. 9. Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, et al. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. (2012) 55:2005-23. 10. European Association for the Study of the Liver, European Association for the Study of Diabetes, European Association for the Study of Obesity. EASL-EASD-EA
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor Dr. Nur Azlina Mohd Fahami, DVM principal investigator
Department of Pharmacology, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palm Tocotrienol Rich Fraction (TRF) and Refined, bleached, and deodorised (RBD) palm olein in people with Alcoholic Fatty Liver Disease, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siti Norain Azahar, Medicine (MD) (60-1126792792, drainazahar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Aspartate Aminotransferase (AST) at 3 and 6 months (time frame: From enrollment to the end of treatment at 3 and 6 months post intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.