NCT05808049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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Fibroscan
研究概览
简要总结
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Sequentially numbered, sealed, opaque envelopes
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged more than equal to 30 and less than or equal to 60 years, diagnosed with NAFLD within last 2 years.
- •CAP scores more than equal to 248 and less than or equal to 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 more than or equal to 25 kg/m
- •Having at least 3 of the following five metabolic risk factors:
- •i Waist circumference: Men: more than or equal to102 cm (40.15 inches); Women more than or equal to 88 cm (34.65 inches).
- •ii Triglycerides >150 mg/dL. iii Blood pressure more than or equal to 130 mm Hg (systolic, SBP) and/or more than or equal to 85 mm Hg (diastolic, DBP).
- •iv Fasting blood glucose more than or equal to 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 Less than or equal to 160 mm Hg (systolic, SBP) and/or less than or equal to 95 mm Hg (diastolic, DBP).
- •Participants with Fasting blood glucose Less than or equal to 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, fructooligo saccharide, 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
Fibroscan
时间窗: Day 120.
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
次要结局
- Lipid Profile(Day 0, 60 and 120)
- serum Lipopolysaccharide level(Day 0 and 120)
- Fibroscan([Time Frame: Day 0, Day 60 and Day 120)
- AST & ALT(Day 0, 60 and 120)
- Inflammatory markers(Day 0 and 120)
研究者
研究点 (4)
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