The study was designed in line with the consolidated standards of reporting trials (CONSORT) guidelines (Schulz, Altman, & Moher, 2010). This investigation conforms to the principles outlined in the Declaration of Helsinki, was approved by the research ethics committee of the University of Navarra (080/2009), and each participant gave written informed consent to the study.
The regular consumption of the high-lycopene tomato sauce induced a significant reduction in the oxidized-LDL cholesterol levels (−9.27 ± 16.8%; p < 0.05). Moreover, total plasma antioxidant capacity tended to increase with the high-lycopene tomato sauce, while it decreased slightly with commercial tomato sauce consumption (2.69 ± 13.4 vs −0.05 ± 0.4; p = 0.058). Lipid, glucose profile and C-reactive protein concentrations were stable during both intervention periods, as well as anthropometric and body composition variables.
Thus, the daily consumption of 160 g of a high-lycopene tomato sauce improved oxidized-LDL cholesterol levels, evidencing the putative role of lycopene in combination with other bioactive compounds in the prevention of oxidative stress related diseases.