A Randomised Double-blind Controlled Trial on Tocotrienol as a Treatment for Non-alcoholic Fatty Liver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Fat percentage before and after intervention in percentage
研究概览
简要总结
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.
详细描述
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 0.05 and a power of 0.8.
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, antibiotics/probiotics, 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 E/placebo administration. Firstly, anthropometric data was gathered for their physical measurement. Besides that, FibroScan and LiverFast analysis to examine the liver health condition. Other than that,molecular 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Fat percentage before and after intervention in percentage
时间窗: 6 months
The measurement were taken using TANITA machine for fat percentage (%) before and after taking vitamin E/Placebo
Fat free mass in kilogram before and after intervention
时间窗: 6 months
The measurement were taken using TANITA machine for fat mass, and fat free mass in kilogram, before and after taking vitamin E or Placebo
Basal metabolic rate in kJ before and after intervention
时间窗: 6 months
The measurement were taken using TANITA machine for BMR (kJ) before and after taking vitamin E or Placebo
Body Mass Index in kg/m2 before and after intervention
时间窗: 6 months
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
Visceral fat before and after intervention
时间窗: 6 months
The measurement were taken using TANITA machine for visceral fat before and after taking vitamin E or Placebo
Liver stiffness based on CAP score before and after intervention
时间窗: 6 months
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.
Fatty changes in kPA before and after intervention
时间窗: 6 months
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.
Fibrosis via Fibrotest before and after intervention
时间窗: 6 months
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.
Inflammation ActiTest before and after intervention
时间窗: 6 months
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.
Steatosis via SteatoTest before and after intervention
时间窗: 6 months
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.
mRNA gene expression level of inflammatory cytokines before and after intervention
时间窗: 6 months
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.
DNA damage analysis via Comet assay before and after intervention
时间窗: 6 months
Comet assay were conducted to access the DNA damage in the eukaryotic cells via blood sample before and after taking vitamin E/Placebo
次要结局
- Plasma Protein(6 months)
- Liver enzymes(6 months)
- Triglyceride levels(6 months)
- Fasting glucose levels(6 months)
- Total cholesterol levels(6 months)
- International Physical Activity Questionnaire (IPAQ)(6 months)
- Food Frequency Questionnaire (FFQ)(6 months)