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

NCT ID: NCT05523024

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Non Alcoholic Fatty Liver Obesity

Keywords

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NAFL; obesity; probiotics; berberine; microbiota;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic

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

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type 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.

Berberine

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

Intervention: Dietary Supplement: Berberine

Group Type ACTIVE_COMPARATOR

Berberine

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Probiotics and Berberine

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

Group Type ACTIVE_COMPARATOR

Probiotc and Berberine

Intervention Type 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.

Interventions

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Probiotic

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.

Intervention Type DIETARY_SUPPLEMENT

Berberine

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Probiotc and Berberine

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pawel Bogdanski

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paweł Bogdański, Professor

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Medical Sciences, Poznan, Poland

Locations

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

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Małgorzata Moszak, PhD

Role: CONTACT

Phone: +48-6185-49-377

Email: [email protected]

Monika Szulińska, DSc

Role: CONTACT

Phone: +48-6185-49-377

Facility Contacts

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Małgorzata Moszak, PhD

Role: primary

Other Identifiers

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491/20;

Identifier Type: -

Identifier Source: org_study_id