Abstract
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 Citrus limon (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, p < 0.005) and 12 (85.0 [80.0, 90.0] cm, p < 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 (p = 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.
Highlights
A healthy lifestyle in youth is a very effective method to address the worldwide cardiovascular disease (CVD) epidemic, the primary cause of mortality in the world with markedly increased prevalence of coronary heart disease (CHD) [1,2]
The analyses revealed the presence of the natural sugars glucose, fructose, and sucrose, the organic acids isocitric and malic, and the flavonoids eriocitrin and hesperidin
After 6 months of lemon juice consumption (300 mL/daily), based on a mixture of juice citrus (95%) with 5% of A. melanocarpa extract, a significant difference in plasma cholesterol, lowdensity lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL)-C was found in subjects with the metabolic syndrome (MetS), when compared to baseline values, the same changes were not seen in the control group [31]
Summary
Nutraceuticals are products containing one or more compounds derived from plants, administered in a suitable pharmaceutical form that can be consumed as dietary supplements or as part of conventional food or beverages. They have been shown to improve well-being and life quality by reducing the risk of disease development or beneficially affecting primary body functions [5]. Appropriate, timely, and continuous monitoring and control of modifiable risk factors, such as dyslipidemia and, in particular, high levels of low-density cholesterol (LDL-C), may have an important role in CVD prevention.
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