Effect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.

NCT05523024 | Unknown

• 1 other identifier: 491/20;
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Alcoholic Fatty Liver; Obesity

Keywords

NAFL; obesity; probiotics; berberine; microbiota;

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (28)

• Changes in blood pressure.

  At the baseline and 12 weeks of treatment

• Changes in weight.

  At the baseline and 12 weeks of treatment

• Changes in waist circumference, hip circumference.

  At the baseline and 12 weeks of treatment

• Changes in waist to hip ratio.

  At the baseline and 12 weeks of treatment

• Changes in BMI.

  At the baseline and 12 weeks of treatment

Study Arms (4)

Probiotic

ACTIVE COMPARATOR

Individuals receive Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily, for 12 weeks. Intervention: Dietary Supplement: Probiotic

Dietary Supplement: Probiotic

Berberine

ACTIVE COMPARATOR

Individuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Berberine

Dietary Supplement: Berberine

Placebo

PLACEBO COMPARATOR

Individuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo

Dietary Supplement: Placebo

Probiotics and Berberine

ACTIVE COMPARATOR

Individuals receive: Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily and Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Probiotic and Berberine

Dietary Supplement: Probiotc and Berberine

Interventions

Probiotic DIETARY_SUPPLEMENT

The probiotic group will receive one capsule of the probiotic mixture (dose:1x109 colony forming units (CFU) per day in one dose (before breakfast). The PRO preparation will contain the following bacterial strains: 50% Lactococcus lactis Rosell® - 1058, 25% Lactobacillus casei Rosell® - 215, 12,5% Lactobacillus helveticus Rosell® - 52, 12,5% Bifidobacterium bifidum Rosell® - 71). Probiotics will be administered orally.

Probiotic

Berberine DIETARY_SUPPLEMENT

The berberine group will receive 1500 mg of Berberine (Berberine hydrochloride 97% extract of Berberis aristata) per day in 3 doses. Berberine will be administered orally, before breakfast, dinner, and before supper.

Berberine

Placebo DIETARY_SUPPLEMENT

The placebo group will receive a placebo. Placebo will contain only the excipients and will be administered orally for 24 weeks. Placebo in no way: color, taste, smell, form of taking, the dosage will not differ from the preparations tested. However, it will not contain probiotcs or berberine. Placebo will be orally administered three times a day: before breakfast, dinner, and supper (6.00-7.00 p.m.). To meet the GCP conditions, subjects from all groups will receive the same number of capsules (six) per day.

Placebo

Probiotc and Berberine DIETARY_SUPPLEMENT

Probiotics and Berberine groupwill receive both: a probiotics mixture (as in PRO group: 1x109 CFU/day; in one dose) and 1500 mg/day of Berberine (Berberine hydrochloride 97% extract of Berberis aristata; in 3 doses). Probiotcs and berberine will be administered orally before breakfast, before dinner, and before supper.

Probiotics and Berberine

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

2 Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznań University of Medical Sciences,

Poznan, 60-569, Poland

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Probiotics; Berberine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paweł Bogdański, Professor

  Poznan University of Medical Sciences, Poznan, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Małgorzata Moszak, PhD

CONTACT

+48-6185-49-377; mmoszak@ump.edu.pl

Monika Szulińska, DSc

CONTACT

+48-6185-49-377

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: August 31, 2022
• Study Start: August 2, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)