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Parameters reflecting cardiovascular health and inflammation were studied in a pilot clinical trial conducted on 40 patients with prehypertension. The patients were treated with a new proprietary formulation of a whey protein (WP) isolate embedded into lycopene micelles (WPL) during a 1-month period. Control groups received lycopene or WP as a singular formulation or placebo pills for the same period of time. Combined WPL formulation of whey protein and lycopene has caused multiple favorable changes in the cardiovascular function (including a tendency to the reduced systemic blood pressure), the plasma lipid profile, and the inflammatory status of patients with prehypertension, whereas singular formulations of the compounds and placebo did not have such an effect. The reduction of plasma triglycerides and cholesterol fractions and almost two-fold decline in C-reactive protein (CRP) and inflammatory oxidative damage (IOD) levels as well as an increase in nitric oxide (NO), tissue oxygenation (StO2), and flow-mediated dilation values constitute the most significant benefit/outcome of the treatment with the combined formulation of whey protein and lycopene. The treatment did not affect the values of ankle-brachial index (ABI), body weight, and body mass index (BMI).

Oxidative stress and antioxidant deficiency play a pivotal role in initiation, development, and outcomes of cardiovascular disease. Pharmacokinetic parameters as well as the impact of highly bioavailable lycopene on cardiovascular variables, markers of inflammation and oxidation were investigated during a 30‐day clinical trial in patients with coronary vascular disease. The patients were randomized into two major groups and were supplemented with a single 7 mg daily dose of lycopene ingested either in the form of lactolycopene (68 patients) or in the form of lycosome‐formulated GA lycopene (74 patients). The endpoints included cardiovascular function parameters, serum lipids, and four markers of oxidative stress and inflammation. Ingestion of lycosome‐formulated lycopene increased serum lycopene levels by 2.9‐ and 4.3‐fold, respectively, after 2 and 4 weeks of the trial, whereas supplementation with lactolycopene upregulated serum lycopene by half‐fold only after 4 weeks of ingestion. Lycosome formulation of lycopene resulted by the end of the trial in a threefold reduction in Chlamydia pneumoniae IgG and reduction to the same degree of the inflammatory oxidative damage marker. The decrease in oxidized LDL caused by lycosome‐formulated lycopene was fivefold. Moreover, supplementation with lycosome‐formulated lycopene was accompanied by a significant increase in tissue oxygenation and flow‐mediated dilation by the end of the observational period. In contrast, lactolycopene did not cause any significant changes in the parameters studied. Therefore, enhanced bioavailability of lycopene promotes its antioxidant and anti‐inflammatory functions and endorses a positive effect of lycopene on cardiovascular system. Supplementation with lycosome‐formulated lycopene was accompanied by a significant increase in tissue oxygenation and flow‐mediated dilation at the end of the observational period. In contrast, lactolycopene did not cause any significant changes in the parameters studied.

Thirty two individuals aged 40–65 years old with a moderate hyperlipidemia (serum triglycerides > 150 mg/dl and LDL from 130 to 160 mg/dl) were supplemented once daily for 30 days with a 250 mg conventional formulation of docosahexaenoic acid (DHA) without lycopene (CF‐DHA) or 250 mg of lycosome‐formulated DHA containing 7 mg of lycopene (LF‐DHA). It was shown that ingestion of CF‐DHA led to a transient increase in serum DHA level after 2 weeks of the trial, whereas LF‐DHA did not cause significant changes in serum DHA. However, there was a noticeable increase in serum eicosapentaenoic acid levels exceeding the pretreatment value by 42.8% and 39.1% after the 2nd and 4th weeks of LF‐DHA ingestion. Patients supplemented with LF‐DHA showed a significant (19.5 mg/dl, p < 0.05) decline in LDL, which was accompanied by a corresponding decrease in total serum cholesterol and a much stronger reduction in serum triglyceride levels (reduction of medians by 27.5 mg/dl). No changes in HDL were observed. LF‐DHA caused a significant decline in the serum level of malonic dialdehyde (MDA), whereas the components of LF‐DHA, lycopene and DHA, ingested as two separate formulations had a less significant effect on serum MDA. Moreover, LF‐DHA increased both the plasma oxygen transport and tissue oxygen saturation by the end of the observational period, while lycopene or DHA taken alone, or both of them co‐ingested separately had none or a much less effect on the oxygen turnover parameters. LF‐DHA caused a significant decline in serum levels of malonic dialdehyde (MAD), whereas the components of LF‐DHA—lycopene and DHA ingested as two separate or combined formulation had much smaller effect on serum MAD. Moreover, LF‐DHA increased both the plasma oxygen transport and tissue oxygen saturation at the end of observational period, although lycopene alone or lycopene co‐ingested with DHA had no or much less effect on the oxygen turnover parameters.

Twenty‐nine healthy volunteers aged 47–69 years old were randomly assigned to a 28‐day oral intake of different dark chocolate (DC) formulations. The main group received daily 30 g of proprietary lycopene‐containing (L‐tug) lycosome formulation of DC with enhanced bioavailability of cocoa flavanols. Two control groups daily consumed either 30 g of regular DC alone or along with 7 mg of lycopene, which corresponds to the amount of lycopene ingested with L‐tug formulation. It was found that L‐tug was more efficient in reducing diastolic blood pressure (mean value of −6.22 mmHg, 95% CI: 5.00, 8.00) when compared with the regular DC group (−3.00 mmHg, P < 0.05) or the group which ingested the DC and lycopene as two separate formulations (mean reduction of −4 mmHg, 95% CI: 2.47, 6.00, P = 0.0262). Only marginal superiority for L‐tug formulation in the reduction in systolic blood pressure was seen. However, the L‐tug formulation was the only formulation of DC which affected serum lipids. There was a reduction in total cholesterol (from median 228.00 mg/dL [95% CI: 206.2, 242.5] to 187.00 mg/dL [95% CI: 166.2, 202.2, P < 0.05]) with corresponding decline of low‐density lipoprotein (LDL) cholesterol (from a median of 166.00 mg/dL [95% CI: 130.8, 177.0] to 151.00 mg/dL [95% CI: 122.8, 167.4; P < 0.05]) at the end of the intervention period. Similar decline was seen in serum triglycerides (P < 0.05). Serum high‐density lipoprotein (HDL) cholesterol, glucose levels, and C‐reactive protein (CRP) values remained statistically unchanged in all study groups throughout the intervention period. A superior biological activity of the L‐tug lycosome formulation of DC extending beyond its antihypertensive effect to lipid‐lowering ability opens up new possibilities for the use of DC for health purposes helping to reduce daily caloric intake without compromising on the health benefits of DC consumption. Lycosome formulation of dark chocolate (DC) containing lycopene (L‐tug) has a superior ability to reduce systemic diastolic and systolic blood pressure in prehypertensive individuals as compared to DC alone or a combination of DC and lycopene ingested as two separate formulations.