Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596382
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-12-13
Brief Title:
Tocotrienol As a Treatment for Non-alcoholic Fatty Liver Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Double-blind Controlled Trial on Tocotrienol As a Treatment for Non-alcoholic Fatty Liver
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vitamin Es 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 tocotrienols effectiveness in treating NAFLD expanding our understanding of its therapeutic benefits
Detailed Description:
This is a randomized double-blinded placebo-controlled trial targeted toward patients being diagnosed with non-alcoholic fatty liver disease Patients will be screened and identified from the gastroenterology and hepatology clinic in Universiti Kebangsaan Malaysia Medical Centre Kuala Lumpur The study expects a total of 264 participants to take part in this four-arm investigation requiring a sample size of 66 for each arm with an alpha probability of 005 and a power of 08
The selection of participants is based on established criteria The criteria include being 18 years and above having a high CAP score from FibroScan and elevated ALT levels Patients with chronic liver diseases acute disorders affecting the liver biliary disease cancer and liver cirrhosis were excluded Alcohol intake was monitored with a minimum amount set Any history of bariatric surgery deemed participants unfit for the study Additionally participants must be free from the use of steatogenic medication antibioticsprobiotics and lipid-lowering agents within one to three months before the study
After the screening process participants were assigned to two groups based on metabolic syndrome presence Within each group individuals were randomly selected to receive either a vitamin E supplement or a placebo Each vitamin E capsule contains a certain amount of dosage with a safe concentration for consumption The metabolic group received 100mg of tocotrienol rich-vitamin E while the non-metabolic group received 50mg of tocotrienol rich-vitamin E Meanwhile each placebo capsule does not contain any vitamin E which supplied to both group
Several analyses were performed before and after vitamin Eplacebo administration Firstly anthropometric data was gathered for their physical measurement Besides that FibroScan and LiverFast analysis to examine the liver health condition Other than thatmolecular approach was also conducted to assess the mRNA gene expression level on the selected cytokines such as TNFα IFNγ IL-6 and IL-8 and also observe the DNA damage of the cells using Comet Assay Additionally biochemical blood testing was tested on 10 parameters to measure its concentration levels within the body Lastly each participant was required to answer questionnaires for evaluation on physical activity levels via IPAQ and their dietary patterns through the FFQ
The selection of participants is based on established criteria The criteria include being 18 years and above having a high CAP score from FibroScan and elevated ALT levels Patients with chronic liver diseases acute disorders affecting the liver biliary disease cancer and liver cirrhosis were excluded Alcohol intake was monitored with a minimum amount set Any history of bariatric surgery deemed participants unfit for the study Additionally participants must be free from the use of steatogenic medication antibioticsprobiotics and lipid-lowering agents within one to three months before the study
After the screening process participants were assigned to two groups based on metabolic syndrome presence Within each group individuals were randomly selected to receive either a vitamin E supplement or a placebo Each vitamin E capsule contains a certain amount of dosage with a safe concentration for consumption The metabolic group received 100mg of tocotrienol rich-vitamin E while the non-metabolic group received 50mg of tocotrienol rich-vitamin E Meanwhile each placebo capsule does not contain any vitamin E which supplied to both group
Several analyses were performed before and after vitamin Eplacebo administration Firstly anthropometric data was gathered for their physical measurement Besides that FibroScan and LiverFast analysis to examine the liver health condition Other than thatmolecular approach was also conducted to assess the mRNA gene expression level on the selected cytokines such as TNFα IFNγ IL-6 and IL-8 and also observe the DNA damage of the cells using Comet Assay Additionally biochemical blood testing was tested on 10 parameters to measure its concentration levels within the body Lastly each participant was required to answer questionnaires for evaluation on physical activity levels via IPAQ and their dietary patterns through the FFQ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None