Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT04049396 | Completed DMC

• 1 other identifier: IR.IAU.SRB.REC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects about one-fourth of the global adult population and has a significant mortality rate between 6.3% and 33%.NAFLD can lead to other serious illnesses. The disease is associated with a group of metabolic comorbid conditions, including type 2 diabetes mellitus (T2DM), obesity, hypertension, and hyper-cholesterolemia, which are potential risk factors for progressive liver disease.This study sought to evaluate the therapeutic effect of berberine on the liver function and metabolic profiles of patients with NAFLD. In this context,A six week, open-label randomized controlled trial was conducted in a single medical center at Takestan Hospital, Iran. A total of 281 patients with NAFLD were enrolled and randomly assigned to treatment arm with (n=24) or without (n=24) berberine. All patients had received pre-randomization lifestyle training including recommendations on low-fat diet. Blood examinations were performed to evaluate glucose, lipid profile, and liver enzymes both at the beginning of the study and upon the completion of the trial (day 45). To assess tolerability of the study intervention and any possible adverse events, patients in both groups were required to attend weekly follow-up visits.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD, Berberine, ALP, AST, ALT, FBS, HDL,LDL

Outcome Measures

Primary Outcomes (3)

• Change from baseline of Alanine Aminotransferase (ALT)

  Serum Alanine Aminotransferase concentration (units per liter)

  Baseline and 6 weeks after

• Change from baseline of Aspartate Aminotransferase (AST)

  Serum Aspartate Aminotransferase concentration(units per liter)

  Baseline and 6 weeks after

• Change from baseline of Alkaline Phosphatase( ALP)

  Serum Alkaline Phosphatase concentration (units per liter)

  Baseline and 6 weeks after

Secondary Outcomes (5)

• Change from baseline of fasting blood sugar(FBS)

  Baseline and 6 weeks after

• Change from baseline of total cholesterol (TC)

  Baseline and 6 weeks after

• Change from baseline of LDL-Cholesterol

  Baseline and 6 weeks after

• Change from baseline of HDL - Cholesterol

  Baseline and 6 weeks after

• Change from baseline of Triglyceride (TG)

  Baseline and 6 weeks after

Study Arms (2)

Berberine

EXPERIMENTAL

Berberine (6.25 g/day)

Other: Berberine

Control

NO INTERVENTION

No intervention

Interventions

Berberine OTHER

24 Patient consumed 6,25 g/day Berberine for 6 weeks

Berberine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have an age range between 18 to 65 years(inclusive).
• Patients with Liver fat content assessed by MRS≥13%.
• Patients must meet the criteria for impaired glucose regulation
• Course of diabetic mellitus less than 1 year
• Informed consent signed

You may not qualify if:

• Any causes of chronic liver disease other than NAFLD(such as-but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, etc.);
• Patients with significantly impaired liver function: ALT or AST≥2 times upper limit of normal;
• Patients with type 1 diabetes mellitus or gestational diabetes or special type diabetes;
• Course of diabetes more than 1 years;
• Diabetics patients who have taken or are taking oral glucose-lowering drugs or insulin;
• Diabetics patients with a HbA1c\>7.5% on initial visit;
• Patients with severe diabetes complications(diabetes ketoacidosis, diabetes coma or with symptomatic of diabetes coma; dysfunction of nerve, retinopathy, dysfunction of kidney);
• Patients with a history of clinically significant heart disease(myocardial infarct, heart failure, and/or severe cardiac rhythm);
• Complicating severe infection,within 6 months after operation, severe trauma;
• Patients with excess alcohol consumption≥140g/week(male); ≥70g/week(female);
• Patients have participated other clinical trials within 24 weeks;
• Patients with a history of drug allergy to berberine;
• Patients with gestation or possible gestation or lactation, or males or females expecting gestation during clinical trial;
• Mental diseases patients;
• Those who refuse to sign informed consent;

Sponsors & Collaborators

• Lida Nejati: lead

Study Sites (1)

Sciences & Research Branch,Azad University of Tehran

Tehran, 1477893855, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Berberine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label, randomized controlled trial .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Nutritionist, MSc of Nutrition, Science and Research Branch, Islamic Azad University, Tehran, Iran

Model Details: In this study , samples were randomly divided into two groups receiving and not receiving supplement

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: August 8, 2019
• Study Start: October 1, 2018
• Primary Completion: March 25, 2019
• Study Completion: June 15, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

IR (1)