Hepatic SteatosisPhase 2T3-NAFLNCT04704063
Efficacy and Safety of Tocovid Suprabio 200mg in Non-alcoholic Fatty Liver (NAFL)
A Phase 2 study testing Tocotrienols / Vitamin E in people with Hepatic Steatosis and NAFLD, run by Yuen Kah Hay at 4 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Steatosis, NAFLD
- What is being tested?
- Tocotrienols / Vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 4 sitesMalaysia
- Study dates
- 1 Jan 2021to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
- History of taking medications known to cause liver impairment such as systemic glucocorticoids, tetracyclines, anabolic steroids, valproic acid, or other known hepatotoxins within 3 months prior to study enrollment
- History of major organ transplantation with an existing functional graft.
- Present with signs of acute infection or inflammation at Screening
- Has medical conditions or recent procedures that do not allow for magnetic resonance (MR) assessments
- Pregnant, breast feeding, or female of childbearing potential (unless the participant is on effective contraception methods or underwent bilateral tubal ligation, bilateral oophorectomy or hysterectomy previously)
- Participation in any other interventional trial within the previous three months. Participants enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
- Known history of severe allergy or immunologically mediated disease (e.g., vasculitis, cryoglobulinemia, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management, etc.)
- New treatment with liver-protective supplements such as S-adenosyl methionine (SAM-e), Ursodeoxycholic acid (UDCA), betain, milk thistle (silymarin), soybean phospholipids (EssentialE®), or fish oil, within 1 month prior to study enrollment.
- Treatment with vitamin E tocopherol (at dosage more than 50mg/day) or tocotrienols within 1 month prior to enrollment.
- Treatment using new anti-lipidemic or anti-diabetic agents within 3 months prior to study enrollment.
- Participant having lesions with a propensity to bleed (e.g., bleeding peptic ulcers) and those having a history of hemorrhagic stroke and those with inherited bleeding disorders (e.g., hemophilia) or patients on warfarin.
- Elevation of AST or ALT greater than five times upper limit normal (ULN), approximately 250 IU/L, or alkaline phosphatase more than two times ULN (250-300 IU/L).
Trial locations and contacts
4 sites in 1 country.
Malaysia4 sites
KK Bandar Baru Air Itam
Pulau Pinang, Pulau Pinang, 11500
KK Jalan Perak
Pulau Pinang, Pulau Pinang, 11600
KK Bayan Baru
Pulau Pinang, Pulau Pinang, 11950
Hospital Seberang Jaya (CRC)
Seberang Jaya, Pulau Pinang, 13700
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study, to Assess the Efficacy and Safety of Tocovid Suprabio 200mg in Non-alcoholic Fatty Liver (NAFL)
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.
- Conditions
- Hepatic Steatosis, NAFLD
- Being tested
- Tocotrienols / Vitamin E, Placebo control
- Keywords
- Tocotrienols, Palm tocotrienol complex, NAFLD, Hepatic Steatosis, Vitamin E, Fatty Liver
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienols / Vitamin EDrug
Also called Tocovid Suprabio
Palm Tocotrienols complex
Placebo controlDrug
Also called Placebo capsule
Placebo matching Tocovid Suprabio
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Tocovid Suprabio 200mg Receives: Drug: Tocotrienols / Vitamin E |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (4)
Change in liver biochemistry
Between group difference in mean change of liver biochemistries (ALT, AST, GGT, AP, Bilirubin)
Measured: 12 months
Change in liver fat fraction
Between group difference in mean change (%) from Baseline to 12 months in hepatic fat fraction by MRI-VLFF
Measured: 12 months
Change in serum lipid profile
Between group difference in mean change of serum lipid profile
Measured: 12 months
Occurrence of adverse events and serious adverse events
Between group difference in the occurrence of adverse events and serious adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Jan 2021
- Primary completion15 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuen Kah Hay
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University Malaysia, Hovid Berhad
- Responsible party
- Sponsor-investigator, Yuen Kah Hay, Universiti Sains Malaysia
- Investigators
- Kah Hay Yuen, PhD, Study chair, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704063
- Sponsor's protocol ID
- T3-NAFL-01-2019
- Acronym
- T3-NAFL
- Status last verified
- May 2024
- First submitted
- 7 Jan 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study, to Assess the Efficacy and Safety of Tocovid Suprabio 200mg in Non-alcoholic Fatty Liver (NAFL)
- ClinicalTrials.gov ID
- NCT04704063
- Acronym / sponsor ID
- T3-NAFL / T3-NAFL-01-2019
- Conditions
- Hepatic Steatosis, NAFLD
- Keywords
- Tocotrienols, Palm tocotrienol complex, NAFLD, Hepatic Steatosis, Vitamin E, Fatty Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Yuen Kah HayUniversity, hospital or other
- Collaborators
- Monash University Malaysia, Hovid Berhad
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Tocotrienols / Vitamin ETocovid Suprabio 200mg |
| Placebo | Placebo comparator | Drug: Placebo controlPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (27 listed)
- 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:
- 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
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 |
|---|---|---|
| Tocotrienols / Vitamin EAlso: Tocovid SuprabioPalm Tocotrienols complex | Drug | Active |
| Placebo controlAlso: Placebo capsulePlacebo matching Tocovid Suprabio | Drug | Placebo |
Primary outcome
Reduction of Liver Fat (VLFF)
Time frame: 12 months
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)
4 secondary outcomes
Change in liver biochemistry
Time frame: 12 months
Change in liver fat fraction
Time frame: 12 months
Change in serum lipid profile
Time frame: 12 months
Occurrence of adverse events and serious adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatic Steatosis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Active, not recruiting
Quantitative Ultrasound (RS85 and R20) for Liver Fat Quantification in MASLD Using MRI-PDFF as Reference
Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatic Steatosis
Active, not recruitingObservational study
Biomarkers of Steatohepatitis in Type 2 Diabetes Patients
Diabetes, Steatosis of Liver
RecruitingPhase 4
Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)
Metabolic Dysfunction-Associated Steatohepatitis, Hepatic Steatosis
Recruiting
Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis
Type 2 Diabetes, Hepatic Steatosis
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. This study is not recruiting at the moment.
Kah Hay Yuen, PhD study chair
Universiti Sains Malaysia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocotrienols / Vitamin E in people with Hepatic Steatosis and NAFLD, run by Yuen Kah Hay at 4 sites 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 3 inclusion and 27 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: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Liver Fat (VLFF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.