Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial
Authors' conclusion
In this randomized clinical trial of diabetes-free individuals with obesity and MASLD, a 6-month berberine treatment at a daily dose of 1 g had an excellent safety profile but did not reduce VAT area or liver fat content.
Study context
- Population
- Diabetes-free individuals with obesity and MASLD, 11 hospitals in China, July–December 2023; mean (SD) age 41.8 (10.6) years, 65.6% malerandomized
- Participants
- 337 individuals
- Comparison
- Oral berberine 1 g/d vs placebo
- Berberinen = 169
- Placebon = 168reference
- Primary endpoint
- Relative percentage change in visceral adipose tissue (VAT) area and absolute change in liver fat content, assessed by CT
- Follow-up
- 6 months
Methodological detailsmulticenter, double-blind, placebo-controlled
- Multicenter
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Estimate (97.5% CI)
Between Berberine and Placebo
difference in VAT area 1.4 %(−2.4% to 5.2%)
Between Berberine and Placebo
difference in liver fat content 0.9 %(−0.4% to 2.1%)
Secondary outcomes
| Outcome | Estimate | |
|---|---|---|
| Change in LDL-C, apolipoprotein B and hs-CRP · 6 months | difference in LDL-C −7.72 mg/dL (95% CI −13.13 to −1.93) | |
| Change in LDL-C, apolipoprotein B and hs-CRP · 6 months | difference in apolipoprotein B −3.42 mg/dL (95% CI −6.33 to −0.51) | |
| Change in LDL-C, apolipoprotein B and hs-CRP · 6 months | difference in hs-CRP −0.072 mg/dL (95% CI −0.140 to −0.004) | |
| −20−10010Difference, mg/dL (linear scale) |
Mean
| Outcome | Berberine | Placebo |
|---|---|---|
| Medication adherence | 90.3% (SD 14.7%) | 90.7% (SD 17.4%) |
Change in LDL-C, apolipoprotein B and high-sensitivity C-reactive protein (hs-CRP) · 6 months
- No differences in other secondary outcomes
Post hoc: higher baseline hs-CRP subgroup
- Consistent patterns of larger reductions in LDL-C, apolipoprotein B and hs-CRP with higher baseline hs-CRP
- Post hoc analysis
Safety
- Incidence of adverse events similar between arms
Original publication
Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial. JAMA Netw Open. Published 2 January 2026. doi:10.
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