Obesity Clinical Trial
Official title:
Effect of Probiotics or Berberine Supplementation on Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL - A Randomized Double- Blind Clinical Study.
NCT number | NCT05523024 |
Other study ID # | 491/20; |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2, 2022 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | June 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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); - T2D; - 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. |
Country | Name | City | State |
---|---|---|---|
Poland | 2 Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences, | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Fibrosis-4 (FIB-4) - Index for Liver Fibrosis. | FIB-4 will be estimated using a medical calculator (based on parameters as: age, ALT, AST, and platelet count). | At the baseline and 12 weeks of treatment | |
Primary | Changes in HSI - Hepatic Steatosis Index. | HSI will be estimated using a medical calculator (based on parameters as: gender, ALT, AST, BMI, and type 2 diabetes). | At the baseline and 12 weeks of treatment | |
Primary | Changes in NAFLD-LFS (liver fat score). | 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). | At the baseline and 12 weeks of treatment | |
Secondary | Changes in blood pressure. | Resting seated BP (both systolic and diastolic) will be measured using a brachial cuff (Omron Healthcare, Kyoto, Japan) three times at 2-min intervals, and the average value will be calculated. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in weight. | Weight will be measured in light clothing and without metal objects (i.e., belt, jewelry). Weight will be measured to the nearest 0.1 kg. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in waist circumference, hip circumference. | WC will be measured between the iliac crest and the lower rib at the end of a normal expiration, and HC will be measured around the widest portion of the buttocks. Both HC and WC will be measured using stretch-resistant medical tape (Seco) to the nearest 0.5 cm. The measurement of WC and HC will be performed according to the World Health Organization (WHO) protocol. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in waist to hip ratio. | WHR will be calculated as WC to HC quotient. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in BMI. | BMI will be calculated according to the formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in fat mass content in the body. | The fat mass content [in kg] in the body will be estimated using BIA methods (InBody 270 and Bioscan 920-2), | At the baseline and 12 weeks of treatment | |
Secondary | Changes in pulse wave velocity (PWV). | The pulse wave velocity (PWV) will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in pulse wave analysis (PWA). | The pulse wave analysis (PWA)will be measured using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia) in a temperature-controlled room before making anthropometric measurements and blood collection. | At the baseline and 12 weeks of treatment | |
Secondary | Gut (taxonomic and functional) microbiota analysis in stool. | Analyzed by the NGS method. | At the baseline and 12 weeks of treatment | |
Secondary | Short-chain fatty acids (SCFAs) concentration in stool. | Analyzed using gas chromatography (Agilent Technologies 1260 A GC system with a flame ionization detector (FID)) | At the baseline and 12 weeks of treatment | |
Secondary | Measurement of hair minerals (Fe, Mg, Ca, Cu, Zn) concentration. | Performed using atomic absorption spectrometry (Atomic Absorption Spectrophotometer ZA3000, Hitachi, Tokyo, Japan) | At the baseline and 12 weeks of treatment | |
Secondary | Changes in ALT, AST, GGT | The ALT, AST, GGT will be measured using standard methods. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in non-esterified free fatty acids. | The NEFA will be measured using standard methods. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in lipids profile (TC, HDL, TG). | The TC, HDL, TG will be measured using standard methods. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in low-density lipoprotein (LDL). | The low-density lipoprotein cholesterol (LDL) will be calculated according to the Friedwald equation. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in fasting glucose level. | The fasting glucose level will be measured using standard methods. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in fasting insulin level. | The ELISA will be used in the estimation. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in insulin resistance index (HOMA-IR) | The HOMA-IR will be calculated according to formula:
HOMA-IR = (insulin * glucose) / 22.5 for the glucose concentration in mmol/L, or: HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases, the insulin is in mU/L. |
At the baseline and 12 weeks of treatment | |
Secondary | Changes in parameter of liver damage: cytokeratin 18. | The ELISA will be used in the estimation cytokeratin 18 (ccK18). | At the baseline and 12 weeks of treatment | |
Secondary | Changes in parameter of liver damage: Glutathione S-transferase (GST). | The ELISA will be used in the estimation GST. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in parameter of liver damage: collagen IV. | The ELISA will be used in the estimation collagen IV. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in parameter of liver damage: hyaluronic acid. | The ELISA will be used in the estimation hyaluronic acid. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in hsCRP. | The hsCRP will be measured using ELISA. | At the baseline and 12 weeks of treatment | |
Secondary | Changes in pentraxin 3. | The pentraxin 3 (PTX3) will be measured using ELISA. | At the baseline and 12 weeks of treatment | |
Secondary | Gut barrier integrity parameter: calprotectin. | The ELISA, will be used in the estimation. | At the baseline and 12 weeks of treatment | |
Secondary | Gut barrier integrity parameters: liver fatty acid-binding protein (L-FABP), intestinal fatty acid-binding protein (I-FABP). | The ELISA, will be used in the estimation. | At the baseline and 12 weeks of treatment | |
Secondary | Gut barrier integrity parameters: lipopolysaccharide (LPS). | The ELISA, will be used in the estimation. | At the baseline and 12 weeks of treatment | |
Secondary | Cardiometabolic risk. | Cardiometabolic risk will be estimated at baseline and after 3 months of treatment using the SCORE scale. SCORE scale summarize 5 risk factors (sex, age, systolic blood pressure, total cholesterol and smoking). | At the baseline and 12 weeks of treatment |
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