Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD

NCT05647915 | Completed Phase 4 DMC

• 1 other identifier: 2021-CXGC04-2
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.

Conditions

Obesity; Obesity, Abdominal; NAFLD

Keywords

berberine hydrochloride

Outcome Measures

Primary Outcomes (2)

• Change of visceral fat content

  Measurement of visceral fat by computed tomography

  6 months

• Change of liver fat content

  Measurement of liver fat content by computed tomography

  6 months

Secondary Outcomes (26)

• Change of fasting plasma glucose

  6 months

• Change of HbA1c

  6 months

• Change of 2-hour postprandial blood glucose

  6 months

• Change of homeostatic model assessment-insulin resistance

  6 months

• Change of homeostasis model assessment-β cell

  6 months

Other Outcomes (16)

• Change of alanine aminotransferase

  6 months

• Change of aspartate aminotransferase

  6 months

• Change of γ-GGT

  6 months

Study Arms (2)

berberine group

EXPERIMENTAL

Berberine hydrochloride plus lifestyle intervention

Drug: Berberine plus lifestyle intervention

placebo group

PLACEBO COMPARATOR

Placebo plus lifestyle intervention

Behavioral: Placebo plus lifestyle intervention

Interventions

Berberine plus lifestyle intervention DRUG

berberine hydrochloride 500mg twice a day for 6 months plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.

berberine group

Placebo plus lifestyle intervention BEHAVIORAL

Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.

placebo group

Eligibility Criteria

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

You may qualify if:

• Participants aged ≥18 years
• Participants with obesity (i.e., BMI ≥ 28 kg/m2) and abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
• Participants with NAFLD diagnosed by ultrasound, computed tomography or magnetic resonance imaging

You may not qualify if:

• Patients with established coronary heart disease, stroke, or peripheral arterial disease
• Patients diagnosed with diabetes or taking oral glucose-lowering drugs
• Patients with severely uncontrolled hypertension (i.e., SBP≥180mmHg and/or DBP ≥110mmHg)
• Excess alcohol consumption (i.e., alcohol ≥ 20 g/day in female or alcohol ≥ 30 g/day in male)
• Other causes of fatty liver disease, including alcohol or drug abuse, hepatitis B or C, autoimmune, hepatolenticular degeneration, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, β -lipoprotein deficiency, lipid atrophy diabetes, Mauriac syndrome, etc.
• Patients with thyroid disease, including hyperthyroidism or hypothyroidism
• Patients with cardiac insufficiency
• ALT or AST ≥ 3 times upper limit of normal, liver cirrhosis or hepatic insufficiency
• Patients with renal insufficiency: estimated glomerular filtration rate (eGFR) \< 60 ml/(min×1.73m2)
• Patients who had weight loss surgery, or are currently taking drugs for weight loss, or plan to have weight loss surgery or drugs in the following 6 months
• Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Taking berberine or drug containing berberine in the past 1 month
• Any adverse reaction to berberine
• Severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
• Patients who had to use long-term or intermittent corticosteroids, immunosuppressants, antibiotics, or other drugs that affect inflammatory biomarkers

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

Beijing, China

Location

Related Publications (3)

• Yan HM, Xia MF, Wang Y, Chang XX, Yao XZ, Rao SX, Zeng MS, Tu YF, Feng R, Jia WP, Liu J, Deng W, Jiang JD, Gao X. Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease. PLoS One. 2015 Aug 7;10(8):e0134172. doi: 10.1371/journal.pone.0134172. eCollection 2015.

  PMID: 26252777 BACKGROUND

• Harrison SA, Gunn N, Neff GW, Kohli A, Liu L, Flyer A, Goldkind L, Di Bisceglie AM. A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes. Nat Commun. 2021 Sep 17;12(1):5503. doi: 10.1038/s41467-021-25701-5.

  PMID: 34535644 BACKGROUND

• Lei L, Wang B, Zhao L, Li J, Yan X, Jiang J, Wang L, Ren G, Li Y, Cheng X, Yan X, Zhu Y, Guo Y, Zhong H, Zhang H, Li J; BRAVO Collaborative Group. Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2554152. doi: 10.1001/jamanetworkopen.2025.54152.

  PMID: 41543854 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Abdominal; Non-alcoholic Fatty Liver Disease

Interventions

Berberine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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 Officials

• Jing Li, PhD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Haibo Zhang, MD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data manager and statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 13, 2022
• Study Start: July 6, 2023
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)