NCT04704063已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study, to Assess the Efficacy and Safety of Tocovid Suprabio 200mg in Non-alcoholic Fatty Liver (NAFL)
Yuen Kah Hay4 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Reduction of Liver Fat (VLFF)
研究概览
简要总结
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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).
研究组 & 干预措施
Active
Active Comparator
Tocovid Suprabio 200mg
干预措施: Tocotrienols / Vitamin E (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo control (Drug)
结局指标
主要结局
Reduction of Liver Fat (VLFF)
时间窗: 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)
次要结局
- Change in liver fat fraction(12 months)
- Occurrence of adverse events and serious adverse events(12 months)
- Change in serum lipid profile(12 months)
- Change in liver biochemistry(12 months)
研究者
Yuen Kah Hay
Professor
Universiti Sains Malaysia
研究点 (4)
Loading locations...
相似试验
撤回
2 期
Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the BloodCholesterol LoweringNCT02142569University of California, Los Angeles
终止
3 期
Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the BloodHypercholesterolemiaNCT02634606University of California, Los Angeles13
已完成
2 期
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.Breast CancerNCT04496492Fondazione IRCCS Istituto Nazionale dei Tumori, Milano50
招募中
不适用
Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Participants with MASLDNon-Alcoholic Fatty Liver DiseaseNCT06704321Valbiotis70
已完成
3 期
Neuroprotection by Tocotrienols in Type 1 and Type 2 Diabetes MellitusCognitive ImpairmentDiabetic NeuropathyNCT01973400Universiti Sains Malaysia300