NCT05523024Unknown不适用
Effect of Probiotics or Berberine Supplementation on Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL - A Randomized Double- Blind Clinical Study.
Poznan University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis.
研究概览
简要总结
Effect of oral selected Probiotics (PRO) and/or Berberine (BBR) supplementation on hepatic steatosis markers, cardiometabolic profile, and gut microbiota profile in the non-alcoholic fatty liver (NAFL) - a randomized double-blind clinical study.
详细描述
Probiotics (PRO) and bioactive natural substances such as Berberine (BBR) can improve metabolic parameters in patients with obesity and metabolic disorders. In addition, they significantly affect the composition and function of gut microbiota (GM) and support anti-inflammation and antioxidant defense. These data have become the starting point for the proposed multidirectional approach, aimed at assessing the effect of PRO and/or BBR supplementation on:
- hepatic-related outcomes,
- changes in anthropometric measurements (body mass, BMI, body mass composition and fat mass % content),
- cardiometabolic profile (e.g. blood pressure, noninvasive markers of endothelial function, cardiometabolic biochemical parameters)
- microbiotic profile (gut microbiota composition, endotoxemia)
- the content of the minerals, in overweight/obese patients with nonalcoholic fatty liver (NAFL).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40 to 60 years;
- •women ≥1 year since last menstruation;
- •body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- •abdominal obesity-related waist circumference > 80 cm (women) and >94 cm (men) (in accordance to International Diabetes Federation);
- •stable body weight in the 3 months prior to the trial (permissible deviation is ± 3 kg);
- •NAFL - diagnosed based on USG in accordance with PGE-NAFLD recommendation
排除标准
- •history of following alternative diets within 3 months before the study;
- •history of use of any dietary supplements in the 3 months before the study;
- •history of intake of antibiotics, probiotics, prebiotics within 3 months before the study;
- •secondary form of obesity, pharmacological treatment for obesity (in the 3 months before the study), history of bariatric surgery;
- •another liver diseases: high risk of NASH (assessed on the FIB-4, according to the PGE-NAFLD recommendation), autoimmune hepatitis, hepatitis B and C, toxic hepatitis, cirrhosis, Wilson's disease, hemochromatosis;
- •other gastrointestinal disorders, especially: IBD, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of IBS;
- •clinically significant acute inflammatory process (elevated hsCRP);
- •abnormal kidney function (GFR <60mL/min/1,73m2);
- •dyslipidemia or hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- •pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- •diseases requiring nutritional requirement and chronic supplementation;
- •alcohol (>30g/d for men and >20g/d for women), nicotine or drug abuse;
- •mental disorders, including eating disorders;
- •cancer, autoimmune diseases;
- •any other condition which may influence on final results of the study or pose a risk for subjects health.
结局指标
主要结局
Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis.
时间窗: At the baseline and 12 weeks of treatment
FIB-4 will be estimated using a medical calculator (based on parameters as: age, ALT, AST, and platelet count).
Changes in NAFLD-LFS (liver fat score).
时间窗: At the baseline and 12 weeks of treatment
NAFLD-LFS will be estimated using a medical calculator (based on serum aspartate transaminase/alanine transaminase (AST/ALT) ratio, fasting serum aspartate transaminase (AST) level, fasting serum insulin level, presence of metabolic syndrome and diabetes mellitus).
Changes in HSI - Hepatic Steatosis Index.
时间窗: At the baseline and 12 weeks of treatment
HSI will be estimated using a medical calculator (based on parameters as: gender, ALT, AST, BMI, and type 2 diabetes).
次要结局
- Changes in hsCRP.(At the baseline and 12 weeks of treatment)
- Changes in pulse wave analysis (PWA).(At the baseline and 12 weeks of treatment)
- Changes in insulin resistance index (HOMA-IR)(At the baseline and 12 weeks of treatment)
- Changes in non-esterified free fatty acids.(At the baseline and 12 weeks of treatment)
- Changes in BMI.(At the baseline and 12 weeks of treatment)
- Changes in ALT, AST, GGT(At the baseline and 12 weeks of treatment)
- Changes in low-density lipoprotein (LDL).(At the baseline and 12 weeks of treatment)
- Changes in parameter of liver damage: collagen IV.(At the baseline and 12 weeks of treatment)
- Changes in parameter of liver damage: hyaluronic acid.(At the baseline and 12 weeks of treatment)
- Changes in weight.(At the baseline and 12 weeks of treatment)
- Short-chain fatty acids (SCFAs) concentration in stool.(At the baseline and 12 weeks of treatment)
- Changes in waist to hip ratio.(At the baseline and 12 weeks of treatment)
- Changes in pulse wave velocity (PWV).(At the baseline and 12 weeks of treatment)
- Measurement of hair minerals (Fe, Mg, Ca, Cu, Zn) concentration.(At the baseline and 12 weeks of treatment)
- Changes in lipids profile (TC, HDL, TG).(At the baseline and 12 weeks of treatment)
- Changes in fasting insulin level.(At the baseline and 12 weeks of treatment)
- Changes in parameter of liver damage: cytokeratin 18.(At the baseline and 12 weeks of treatment)
- Changes in blood pressure.(At the baseline and 12 weeks of treatment)
- Changes in waist circumference, hip circumference.(At the baseline and 12 weeks of treatment)
- Changes in fat mass content in the body.(At the baseline and 12 weeks of treatment)
- Gut (taxonomic and functional) microbiota analysis in stool.(At the baseline and 12 weeks of treatment)
- Changes in fasting glucose level.(At the baseline and 12 weeks of treatment)
- Changes in parameter of liver damage: Glutathione S-transferase (GST).(At the baseline and 12 weeks of treatment)
- Gut barrier integrity parameter: calprotectin.(At the baseline and 12 weeks of treatment)
- Gut barrier integrity parameters: liver fatty acid-binding protein (L-FABP), intestinal fatty acid-binding protein (I-FABP).(At the baseline and 12 weeks of treatment)
- Cardiometabolic risk.(At the baseline and 12 weeks of treatment)
- Changes in pentraxin 3.(At the baseline and 12 weeks of treatment)
- Gut barrier integrity parameters: lipopolysaccharide (LPS).(At the baseline and 12 weeks of treatment)
研究者
Pawel Bogdanski
Professor
Poznan University of Medical Sciences
研究点 (2)
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