NCT06873412尚未招募不适用
The Regulatory Effect of Probiotics-Polygonatum Sibiricum on Liver Health and Metabolic Disorders in Middle-Aged and Elderly People: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- Changes in alanine aminotransferase (ALT) levels
研究概览
简要总结
The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observe its effects on liver function indexes, basal metabolic rate, markers of oxidative stress, inflammatory factors and intestinal microecology, and evaluate the incidence of adverse reactions in subjects during the 3-month intervention period.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the subjects is 40-80 years old;
- •The subject meets one of the following metabolic disease components: ① abdominal B - ultrasound shows fatty liver or fat infiltration; ② arterial blood pressure is higher than 130/85mmHg, or the subject is on antihypertensive treatment; ③ prediabetes or type 2 diabetes, with fasting blood glucose above 6.1mmol/L; ④ overweight or obesity, with BMI of 24.0kg/m² or more, or male waist circumference of 90cm or more, female waist circumference of 85cm or more, or excessive body fat content and percentage.
排除标准
- •People who are allergic to any of the pharmaceutical ingredients used in this study; A history of alcohol abuse (drinking more than 14 units of alcohol per week :1 unit = 285mL for beer, 25mL for spirits, 100mL for wine);
- •Patients who received probiotics within 1 month before taking the experimental drug;
- •Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
- •Aminotransferase index > 3 times the normal value;
- •Kidney disease (creatinine index higher than normal);
- •Patients with serious psychological and mental diseases, resulting in the inability to express themselves normally;
- •Patients with infectious liver diseases, such as hepatitis B and C;
- •The female subject is breastfeeding or has a positive pregnancy test result during the screening period or during the test -
结局指标
主要结局
Changes in alanine aminotransferase (ALT) levels
时间窗: 3 months
ALT level decline indicates improved liver function, assessed via blood tests.
Changes in aspartate aminotransferase (AST) levels
时间窗: 3 months
AST level decline indicates improved liver function, assessed via blood tests.
次要结局
- Changes in basal metabolic rate(3 months)
- Metabolic index(3 months)
- Gamma-glutamyltransferase (GGT)(3 months)
- Total bilirubin (TBil)(3 months)
- Uric acid(3 months)
- Weight(3 months)
- BMI (body mass index)(3 months)
- Fasting blood glucose(3 months)
- Total cholesterol(3 months)
- Triglyceride(3 months)
- Low-density lipoprotein (LDL)(3 months)
- High density lipoprotein (HDL)(3 months)
- Changes in malondialdehyde (MDA) levels(3 months)
- Changes in the level of superoxide dismutase (SOD)(3 months)
- Changes in glutathione (GSH) levels(3 months)
- Fatigue Severity Scale (FSS)(3 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- Short-chain fatty acids (SCFAs)(3 months)
- Fecal flora structure (16S rRNA sequencing)(3 months)
- Inflammatory factor(3 months)
- Fatty liver morphology(3 months)
研究者
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