Abstract
BACKGROUND: Despite significant advances in the management of cardiovascular disease (CVDs), there is still a large burden of CVD in the world. The inclusion of functional foods in the diet may provide beneficial effects on CVD. Purple-black barberry due to its richness in anthocyanins and berberine has shown beneficial effects on cardiometabolic factors. We investigated the effects of barberry on plasma lipids as well as inflammatory biomarkers in subjects with cardiovascular risk factors. METHODS: This was an 8-weeks, single-blinded, randomized controlled clinical trial that the participants were randomly assigned to a barberry (10 g/day dried barberry) or placebo group. At baseline and end of the study, plasma lipid profiles including total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), small-dense LDL-C (sd-LDL-C), non-HDL-C, and TC/HDL-C, as well as inflammatory biomarkers including C-reactive protein (CRP) and interleukin-6 (IL-6), were determined. An intention-to-treat analysis was performed. RESULTS: Eighty-four participants were randomly assigned to study groups. The mean (± SD) participants' age was 54.06 ± 10.19 years. Body weight, body mass index (BMI), physical activity, and dietary intake were not different between the two groups at baseline and the end of the study. After adjusting for baseline values, we observed a significant decrease in plasma levels of TG, TC, LDL-C, sd-LDL-C, non-HDL-C, and TC/HDL-C (p < 0.001, p = 0.011, p = 0.015, p = 0.019, p = 0.004, and p = 0.039 respectively) as well as CRP (p = 0.020) in the barberry group compared to the placebo group. CONCLUSIONS: Our results indicate that purple-black barberry consumption decreases plasma levels of CRP and improves lipid profile in subjects with cardiovascular risk factors. TRIAL REGISTRATION: This clinical trial was registered at ClinicalTrials.gov (NCT number: NCT04084847 ).