Raimondo Stefania, Nikolic Dragana, Conigliaro Alice, Giavaresi Gianluca, Lo Sasso Bruna, Giglio Rosaria Vincenza, Chianetta Roberta, Manno Mauro, Raccosta Samuele, Corleone Valeria, Ferrante Giovanni, Citarrella Roberto, Rizzo Manfredi, De Leo Giacomo, Ciaccio Marcello, Montalto Giuseppe, Alessandro Riccardo
Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), Section of Biology and Genetics, University of Palermo, 90133 Palermo, Italy.
Navhetec s.r.l, Via Elvira ed Enzo Sellerio, 90141 Palermo, Italy.
Metabolites. 2021 Apr 27;11(5):276. doi: 10.3390/metabo11050276.
Appropriate monitoring and control of modifiable risk factors, such as the level of low-density lipoprotein cholesterol (LDL-C) and other types of dyslipidemia, have an important role in the prevention of cardiovascular diseases (CVD). Recently, various nutraceuticals with lipid-lowering effects have gained attention. In addition to the plant-derived bioactive compounds, recent studies suggested that plant cells are able to release small lipoproteic structures named extracellular vesicles (EVs). The interaction between EVs and mammalian cells could lead to beneficial effects through anti-inflammatory and antioxidant activities. The present study aimed to assess the safety of the new patented plant-based product citraVes™, containing extracellular vesicles (EVs) from (L.) Osbeck juice, and to investigate its ability to modulate different CV risk factors in healthy subjects. A cohort of 20 healthy volunteers was recruited in a prospective open-label study. All participants received the supplement in a spray-dried formulation at a stable dose of 1000 mg/day for 3 months. Anthropometric and hematobiochemical parameters were analyzed at the baseline and after the follow-up period of 1 and 3 months. We observed that the supplement has an effect on two key factors of cardiometabolic risk in healthy subjects. A significant change in waist circumference was found in women after 4 (85.4 [79.9, 91.0] cm, < 0.005) and 12 (85.0 [80.0, 90.0] cm, < 0.0005) weeks, when compared to the baseline value (87.6 [81.7, 93.6] cm). No difference was found in men (baseline: 100.3 [95.4, 105.2] cm; 4 weeks: 102.0 [95.7, 108.3] cm; 12 weeks: 100.0 [95.3, 104.7] cm). The level of LDL-C was significantly lower at 12 weeks versus 4 weeks ( = 0.0064). Our study evaluated, for the first time, the effects of a natural product containing plant-derived EVs on modifiable risk factors in healthy volunteers. The results support the use of EV extracts to manage cardiometabolic risk factors successfully.
对可改变的风险因素进行适当监测和控制，如低密度脂蛋白胆固醇（LDL-C）水平及其他类型的血脂异常，在预防心血管疾病（CVD）中具有重要作用。最近，各种具有降脂作用的营养保健品受到关注。除了植物来源的生物活性化合物外，最近的研究表明植物细胞能够释放名为细胞外囊泡（EVs）的小脂蛋白结构。EVs与哺乳动物细胞之间的相互作用可通过抗炎和抗氧化活性产生有益效果。本研究旨在评估新的专利植物基产品citraVes™的安全性，该产品含有来自酸橙（L.）奥斯贝克果汁的细胞外囊泡（EVs），并研究其调节健康受试者不同心血管疾病风险因素的能力。在一项前瞻性开放标签研究中招募了一组20名健康志愿者。所有参与者均接受喷雾干燥制剂形式的补充剂，稳定剂量为1000毫克/天，持续3个月。在基线以及随访1个月和3个月后分析人体测量和血液生化参数。我们观察到该补充剂对健康受试者心脏代谢风险的两个关键因素有影响。与基线值（87.6 [81.7, 93.6]厘米）相比，女性在4周（85.4 [79.9, 91.0]厘米，P < 0.005）和12周（85.0 [80.0, 90.0]厘米，P < 0.0005）后腰围有显著变化。男性未发现差异（基线：100.3 [95.4, 105.2]厘米；4周：102.0 [95.7, 108.3]厘米；12周：100.0 [95.3, 104.7]厘米）。与4周相比，12周时LDL-C水平显著降低（P = 0.0064）。我们的研究首次评估了含有植物来源EVs的天然产品对健康志愿者可改变风险因素的影响。结果支持使用EV提取物成功管理心脏代谢风险因素。
