Progetto vincitore della Borsa di Studio SISA 2017 - Ferro




Comparative Study of a Calabria’s tomato sauce rich in carotenoids and  Danacol on the reduction of LDL Cholesterol in subjects with Polygenic Hypercholesterolemia

Yvelise Ferro



Background/Rationale: High LDL Cholesterol (LDL-C) is one of the risk factors of atherosclerosis and atherosclerosis is the principal cause of cardiovascular diseases (CVDs). The benefits of LDL-C reduction on the risk of CVDs and mortality have been clearly established in large trials involving the use of statins. There is a critical need to identity additional effective hypolipemic agents that can be used either in combination with statins, or alone, if statins are not tolerated. In recent years, nutraceuticals and functional foods have attracted much interest as possible alternative therapies to statins, especially for polygenic hypercholesterolemia’s patients, whose blood cholesterol level is marginally high but not high enough to warrant the prescription of statins.
Epidemiological studies indicate that high dietary intakes of carotenoids are associated with a reduced risk of CVDs. Tomatoes is a natural and economic source of carotenoids. In a pilot study, we demonstrated a reduction of 13% of LDL-C in postmenopausal women after intake of 150 mg/day for 3 months of a Calabria’s tomato sauce rich in carotenoid.
Currently there is a commercially available functional food, named Danacol, which is plant sterol-enriched low-fat fermented milk that have cholesterol-lowering proprieties tested in clinical trials. Actually human studies on the efficacy of tomato products on LDL-C levels are poor and no study evaluated the effects on lipid profile of Calabria’s food rich in carotenoid compared to a commercial clinically tested functional food with cholesterol-lowering properties.


Objective of the project: The aim will be to evaluate the effects on LDL-C of a Calabria’s tomato sauce rich in carotenoids compared to Danacol in subjects with polygenic hypercholesterolemia.


Methods and Research strategy: 98 subjects with polygenic hypercholesterolemia without pharmacological therapy will be enrolled in this randomized, single bling, crossover study. All patients will submit to biochemical evaluation. Patients will be randomized into two groups: Group A: 49 subjects will be treated with 150 mg/day of a Calabria’s tomato sauce rich in carotenoids for 6 weeks; Group B: 49 subjects will be treated with 1 bottle of 100 ml of a fresh dairy (Danacol) for 6 weeks. After treatments, each groups will follow for 4 weeks wash-out period with cholesterol-lowering diet. After wash-out period Group A will take the treatment of Group B and Group B will take the treatment of Group A for 6 weeks. All evaluations will be performed each medical visits.


Expected results: Calabria’s tomato sauce rich in carotenoids could be a new functional food with cholesterol-lowering properties and furthermore it could be an efficacy alternative to Danacol on the reduction of LDL-C in polygenic hypercholesterolemia subjects.




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