NCT04704063

Brief Summary

Palm-derived tocotrienols have shown hepatoprotective effects in both animal and human studies. This study aims to investigate the effects of tocotrienols in hepatocellular lipid content using MRI. Non-alcoholic fatty liver disease (NAFLD) is a spectrum of diseases ranging from simple fatty liver (steatosis, NAFL) to non-alcoholic steatohepatitis (NASH) to cirrhosis. NASH is the accumulation of fat in liver cells accompanied with inflammation that can lead to the scarring of the liver. Prevention of liver fibrosis by early introduction of low risk interventions such as lifestyle modification, diet control and nutraceuticals may help circumvent long-term healthcare costs associated with management of chronic NASH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

January 7, 2021

Last Update Submit

May 8, 2024

Conditions

Hepatic SteatosisNAFLD

Keywords

TocotrienolsPalm tocotrienol complexNAFLDHepatic SteatosisVitamin EFatty Liver

Outcome Measures

Primary Outcomes (1)

  • Reduction of Liver Fat (VLFF)

    Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by Magnetic Resonance Imaging - Volumetric Liver Fat Fraction (MRI-VLFF)

    12 months

Secondary Outcomes (4)

  • Change in liver biochemistry

    12 months

  • Change in liver fat fraction

    12 months

  • Change in serum lipid profile

    12 months

  • Occurrence of adverse events and serious adverse events

    12 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Tocovid Suprabio 200mg

Drug: Tocotrienols / Vitamin E

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo control

Interventions

Tocotrienols / Vitamin EDRUG

Palm Tocotrienols complex

Also known as: Tocovid Suprabio
Active
Placebo controlDRUG

Placebo matching Tocovid Suprabio

Also known as: Placebo capsule
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years old.
  • Diagnosis of non-alcoholic fatty liver (NAFL, hepatic steatosis), using ultrasound or Fibroscan
  • Willing to provide written informed consent

You may not qualify if:

  • History or evidence of medical condition(s) associated with chronic liver disease other than NAFL
  • Known history or other evidence of decompensated liver disease (Child-Pugh Grade B or higher), coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, hepatic encephalopathy, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
  • Documented underlying medical conditions which may affect assessment or follow-up as listed:
  • Any malignancies
  • eGFR \< 60
  • Severe dementia or psychosis
  • Requirement of long-term corticosteroid treatment for the underlying disease such as connective tissue disease
  • Uncontrolled Hemoglobinopathy or anemia
  • Uncontrolled Hyperthyroidism or Hypothyroidism
  • Hemochromatosis
  • Hepatobiliary disorders
  • Participant underwent splenectomy or suffered from splenomegaly
  • Hepatitis B or C
  • History of drug or substance abuse.
  • Estimated alcohol consumption of more than 20 g/day (1 standard drink/day) for women or more than 30 g/day (2 standard drinks/day) for men for at least 6 months prior to enrollment, binge drinking behavior or Alcohol Use and Disorders Identification Test (AUDIT) score of 7 or more
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

KK Bandar Baru Air Itam

Pulau Pinang, Pulau Pinang, 11500, Malaysia

Location

KK Jalan Perak

Pulau Pinang, Pulau Pinang, 11600, Malaysia

Location

KK Bayan Baru

Pulau Pinang, Pulau Pinang, 11950, Malaysia

Location

Hospital Seberang Jaya (CRC)

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Interventions

TocotrienolsVitamin E

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kah Hay Yuen, PhD

    Universiti Sains Malaysia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

January 1, 2021

Primary Completion

August 15, 2023

Study Completion

October 1, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

MY(4)