CTRI/2022/06/043558已完成不适用
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult men and women aged ≥30 and ≤60 years, diagnosed with NAFLD within last 2 years.
- •CAP scores ≥248 and ≤270 dB/m indicating steatosis grade I/ II.
- •Non-alcoholics (little or no consumption of alcohol).
- •Willing to participate in the study with a signed and dated written consent.
- •Overweight and obese participant with BMI ≥25 kg/m
- •Having at least 3 of the following five metabolic risk factors: i Waist circumference: Men: ≥ 102 cm (40.15 inches); Women ≥88 cm (34.65 inches).
- •ii Triglycerides >150 mg/dL.
- •iii Blood pressure ≥130 mm Hg (systolic, SBP) and/or ≥85 mm Hg (diastolic, DBP).
- •iv Fasting blood glucose ≥ 100 mg/ dl.
- •v Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL.
排除标准
- •Treatment of NAFLD for at least 3 months prior to the screening.
- •History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
- •Participants with liver cirrhosis, any concomitant liver disease.
- •Participants with systemic inflammatory disease or autoimmune disorders.
- •Participants with blood pressure ≥160 mm Hg (systolic, SBP) and/or ≥95 mm Hg (diastolic, DBP).
- •Participants with Fasting blood glucose ≥ 140 mg/ dl.
- •Participants with cardiopulmonary disease.
- •Heavy alcohol drinkers defined as follows: i For men, consuming more than 4 drinks on any day or more than 14 drinks/week ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week
- •Participants with liver cancer.
- •primary hepatocellular carcinoma or liver metastasis.
- •Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus.
- •Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F
- •Individuals with Inflammatory bowel diseases.
- •Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening.
- •Intake of probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk and proton pump inhibitor within one month before screening or during the study period.
- •Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions.
- •Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- •Regular use of a probiotic or prebiotic supplement within 3 months prior to screening.
- •Antibiotic use within 3 weeks prior to screening.
结局指标
主要结局
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo.
时间窗: Day 0, Day 60 and Day 120
次要结局
- Liver health as assessed by the significant change in the AST & ALT levels from baseline as compared to that in placebo.(Day 0, 60 and 120)
- Lipid profile as assessed by the significant change in the total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides from baseline to end point in comparison to the placebo.(Day 0, 60 and 120)
- The inflammatory factors as assessed by the change in IL-6 and TNF-α from baseline to end point in comparison to the placebo.(Day 0 and 120)
- On dietary endotoxemia as assessed by the significant change in the serum Lipopolysaccharide level after a high fat diet(Day 0 and 120)
研究者
研究点 (2)
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