Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial.

Berberine did not significantly reduce visceral adipose tissue area compared to placebo over 6 months.

• The difference in relative percentage change in VAT area between berberine and placebo was 1.4% (97.5% CI, -2.4% to 5.2%), which was not statistically significant.
• VAT area was assessed by computed tomography.
• Analysis was conducted according to the intention-to-treat principle.
• 337 participants were randomized across 11 hospitals in China between July 6 and December 29, 2023.

Berberine did not significantly reduce liver fat content compared to placebo over 6 months.

• The absolute difference in change in liver fat content between berberine and placebo was 0.9% (97.5% CI, -0.4% to 2.1%), which was not statistically significant.
• Liver fat content was assessed by computed tomography.
• 169 participants received berberine and 168 received placebo.
• Participants had confirmed MASLD and obesity and were diabetes-free.

Berberine was associated with significantly larger reductions in low-density lipoprotein cholesterol compared to placebo.

• The difference in LDL cholesterol change was -7.72 mg/dL (95% CI, -13.13 to -1.93 mg/dL) favoring berberine.
• This was a secondary outcome of the trial.
• The oral berberine dose was 1 g/d for 6 months.
• Mean medication adherence rates were 90.3% (SD 14.7%) for berberine and 90.7% (SD 17.4%) for placebo.

Berberine was associated with significantly larger reductions in apolipoprotein B compared to placebo.

• The difference in apolipoprotein B change was -3.42 mg/dL (95% CI, -6.33 to -0.51 mg/dL) favoring berberine.
• This was a secondary outcome measure.
• No significant differences were observed between study arms for other secondary lipid outcomes.

Berberine was associated with significantly larger reductions in high-sensitivity C-reactive protein compared to placebo.

• The difference in hs-CRP change was -0.072 mg/dL (95% CI, -0.140 to -0.004 mg/dL) favoring berberine.
• Post hoc analyses suggested consistent patterns of larger reductions in LDL cholesterol, apolipoprotein B, and hs-CRP levels in participants with higher baseline hs-CRP levels.
• This was a secondary outcome measure.

The incidence of adverse events was similar between the berberine and placebo groups.

• The safety profile of berberine at 1 g/d for 6 months was described as 'excellent.'
• No significant differences in adverse event incidence were observed between study arms.
• The trial enrolled diabetes-free individuals with obesity and MASLD at 11 hospitals in China.

The study population consisted of diabetes-free individuals with obesity and MASLD with a mean age of 41.8 years, predominantly male.

• Mean (SD) age was 41.8 (10.6) years.
• 221 of 337 participants (65.6%) were male.
• 337 participants were randomized: 169 to berberine and 168 to placebo.
• The trial was multicenter and double-blind, conducted at 11 hospitals in China with a follow-up duration of 6 months.