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RECRUITING

NCT07466485

PHASE2

The Efficacy of Tocotrienol Rich Fraction for Liver Protection in Adult Patients With Alcoholic Fatty Liver Disease (AFLD)

Sponsor: Universiti Kebangsaan Malaysia Medical Centre

View on ClinicalTrials.gov

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). 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.

Official title: The Effect of Palm Tocotrienol Rich Fraction on Alcoholic Fatty Liver Disease (AFLD): A Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-02

Completion Date

2026-12-15

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Alcoholic Fatty Liver Disease

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

Refined, bleached, and deodorised (RBD) palm olein

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.

Inclusion Criteria: 1. Patients with history of alcoholic use disorder with clinical and biochemical evidence of alcoholic steatohepatitis (AST:ALT \>2.0, elevated GGT) 2. Patients with Maddrey's discriminant function ≤ 32, and do not require the treatment of corticosteroid therapy or pentoxifylline. 3. Patients aged 18 to 65 4. Patients who could comply with alcohol abstinence. Exclusion Criteria: 1. Severe alcoholic hepatitis defined as Maddrey's discriminant function \>32 2. Patients with other concomitant liver diseases: 1. Hepatitis B 2. Hepatitis C 3. Non-alcoholic fatty liver disease (NAFLD) 4. Autoimmune hepatitis (AIH) 5. Hereditary hemochromatosis 3. Patients who are obese (a BMI of 30 kg/ m2 or more) and with metabolic syndromes 4. Patients with bleeding disorders and who have been on anticoagulant or antiaggregant treatments 5. Patients who have been on corticosteroid therapy or pentoxifylline for alcoholic hepatitis 6. Patients with hepatocellular carcinoma 7. Pregnant patients 8. Patients who are breastfeeding 9. Patients with Childs C liver cirrhosis 10. Patients who have pyridoxine allergy or history 11. 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. 12. Patients taking vitamin E, herbal supplements, or other investigational products within 90 days prior to the participation in the study. 13. 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) 14. Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study 15. Patients who could not comply with alcohol abstinence. 16. Patient who considered ineligible for participation in the study as Investigator's judgment

Locations (1)

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak

Cheras, Kuala Lumpur, Malaysia