Tocotrienol as a Treatment for Non-alcoholic Fatty Liver Disease

NCT06596382 | Completed DMC

• 2 other identifiers: UKM PPI/111/8/JEP-2020-190FF-2020-180
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin E's potential in treating non-alcoholic fatty liver disease (NAFLD) is attributed to its antioxidant properties. While tocopherols have shown significant results in NAFLD management, the powerful properties of tocotrienols, another form of saturated vitamin E, remain understudied. This research aims to assess tocotrienol's effectiveness in treating NAFLD, expanding our understanding of its therapeutic benefits.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Tocotrienol; Vitamin E; Fatty Liver

Outcome Measures

Primary Outcomes (12)

• Fat percentage before and after intervention in percentage

  The measurement were taken using TANITA machine for fat percentage (%) before and after taking vitamin E/Placebo

  6 months

• Fat free mass in kilogram before and after intervention

  The measurement were taken using TANITA machine for fat mass, and fat free mass in kilogram, before and after taking vitamin E or Placebo

  6 months

• Basal metabolic rate in kJ before and after intervention

  The measurement were taken using TANITA machine for BMR (kJ) before and after taking vitamin E or Placebo

  6 months

• Body Mass Index in kg/m2 before and after intervention

  The measurement were taken using TANITA machine for height and weight and will be combined and reported as body mass index (BMI) in kg/m2 before and after taking vitamin E or Placebo

  6 months

• Visceral fat before and after intervention

  The measurement were taken using TANITA machine for visceral fat before and after taking vitamin E or Placebo

  6 months

• Liver stiffness based on CAP score before and after intervention

  Liver stiffness in the liver was measured using transient elastography technique via FibroScan device, where the evaluation is based on controlled attenuated parameter (CAP) score before and after taking vitamin E/Placebo. CAP score of \> 263 indicates fatty liver. The highest score is 1.0. A higher score denotes a worse outcome.

  6 months

• Fatty changes in kPA before and after intervention

  Fatty changes in the liver was measured using transient elastography technique via FibroScan device where the evaluation is based on kPA before and after taking vitamin E/Placebo.

  6 months

• Fibrosis via Fibrotest before and after intervention

  Blood sample were taken from the patient to determine the degree of liver damage through FibroTest (Fibrosis) based on 10 biomarkers before and after taking vitamin E/Placebo.

  6 months

• Inflammation ActiTest before and after intervention

  Blood sample were taken from the patient to determine the degree of liver damage through ActiTest (Inflammation) based on 10 biomarkers before and after taking vitamin E/Placebo.

  6 months

• Steatosis via SteatoTest before and after intervention

  Blood sample were taken from the patient to determine the degree of liver damage through SteatoTest (Steatosis) based on 10 biomarkers before and after taking vitamin E/Placebo.

  6 months

• mRNA gene expression level of inflammatory cytokines before and after intervention

  Blood sample were taken and extracted for the qualitative determination of mRNA gene expression level of the cytokines (TNFα, IFNγ, IL-6, IL-8) in fold change including housekeeping gene using qPCR method before and after taking vitamin E or Placebo.

  6 months

• DNA damage analysis via Comet assay before and after intervention

  Comet assay were conducted to access the DNA damage in the eukaryotic cells via blood sample before and after taking vitamin E/Placebo

  6 months

Secondary Outcomes (7)

• Plasma Protein

  6 months

• Liver enzymes

  6 months

• Triglyceride levels

  6 months

• Fasting glucose levels

  6 months

• Total cholesterol levels

  6 months

Study Arms (4)

NAFLD with metabolic syndrome; intervention with tocotrienol rich-vitamin E

ACTIVE COMPARATOR

66 patient diagnosed with NALFD and associated with metabolic syndrome were given 100mg of tocotrienol rich-vitamin E for six months

Dietary Supplement: Tocotrienol rich-vitamin E

NAFLD without metabolic syndrome; intervention with tocotrienol rich-vitamin E

ACTIVE COMPARATOR

66 patient diagnosed with NALFD without being associated with metabolic syndrome were given 50mg of tocotrienol rich-vitamin E for six months

Dietary Supplement: Tocotrienol rich-vitamin E

NAFLD with metabolic syndrome; intervention with placebo

PLACEBO COMPARATOR

66 patient diagnosed with NALFD and associated with metabolic syndrome were given placebo for six months

Dietary Supplement: Placebo

NAFLD without metabolic syndrome; intervention with placebo

PLACEBO COMPARATOR

66 patient diagnosed with NALFD without being associated with metabolic syndrome were given placebo for six months

Dietary Supplement: Placebo

Interventions

Tocotrienol rich-vitamin E DIETARY_SUPPLEMENT

Two dosage are available which are 100 mg for NAFLD patient with underlying metabolic syndrome meanwhile 50mg for NALFD patient without metabolic syndrome

NAFLD with metabolic syndrome; intervention with tocotrienol rich-vitamin E; NAFLD without metabolic syndrome; intervention with tocotrienol rich-vitamin E

Placebo DIETARY_SUPPLEMENT

Replicate for tocotrienol rich-vitamin E without any active ingredients

NAFLD with metabolic syndrome; intervention with placebo; NAFLD without metabolic syndrome; intervention with placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of NAFLD is confirmed by the presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score from FibroScan® of \>263 dB/m
• Raised ALT level (above the upper limit of normal): \>35 U/L for males and \>25 U/L for females

You may not qualify if:

• Evidence of other chronic liver diseases (e.g. Hepatitis B, C infections, autoimmune hepatic disorders)
• Evidence of acute disorders affecting the liver (e.g. drug-induced liver injury, non-Hepatitis B, C viral infection)
• Biliary disease
• Liver cancer - primary hepatocellular carcinoma or liver metastasis
• Evidence of liver cirrhosis
• Alcohol intake of \>20 g/day for males and 10 g/day for females
• Use of steatogenic medications within the past three months (e.g. systemic steroids, methotrexate)
• History of bariatric surgery
• Intake of antibiotics and/or probiotic supplements within two months prior to the study
• Intake of a lipid-lowering agent (statin) within a month prior to the study.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized double-blinded placebo-controlled trial was performed toward patients diagnosed with NALFD with several established inclusion and exclusion criteria of study. Two main groups were formed to separate the patient into metabolic syndrome and non-metabolic group. In these groups, it will further divided into two groups where the administration of tocotrienol rich-vitamin E and placebo were given in random manner. Each participant will consume the vitamin/placebo daily for one capsule in the duration of six months. Various assessments was conducted before and after taking the vitamin E/placebo.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: September 19, 2024
• Study Start: October 13, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)