NCT05647915

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

Assess the Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and Non-alcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial aims to evaluate the efficacy and safety of berberine treatment for obesity and NAFLD. Potential eligible patients will be recruited from 10-20 medical centers in China. After a 4-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 1.0 g per day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be asked to attend the visit at least once every 2 months, and be followed up for 6 months.

Conditions

• Obesity
• Obesity, Abdominal
• NAFLD

Interventions

Type	Name	Description
DRUG	Berberine plus lifestyle intervention	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.
BEHAVIORAL	Placebo plus lifestyle intervention	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.

Timeline

• Start date: 2023-07-06
• Primary completion: 2024-08-09
• Completion: 2024-08-09
• First posted: 2022-12-13
• Last updated: 2025-01-29

Locations

1 site across 1 country: China