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Several epidemiological and intervention studies suggest that a high dietary intake of tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is associated with an increased incidence of CVD. This beneficial effects have been attributed especially to lycopene, an antioxidant present in high concentration within tomatoes but other substances could be of importance.
Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the present study is therefore to investigate whether consumption of tomato products ameliorates peripheral endothelial function, triggered by a high fat meal, in human volunteers in a randomised, crossover dietary intervention study.
Study design:
Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).
We hypothesize that tomato sauce can improve the deleterious effects of a high fat meal on vascular function.
Several epidemiological and intervention studies suggest that a high dietary intake of tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is associated with an increased incidence of CVD. This beneficial effects have been attributed especially to lycopene, an antioxidant present in high concentration within tomatoes but other substances could be of importance.
Endothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the present study is therefore to investigate whether consumption of tomato products ameliorates peripheral endothelial function, triggered by a high fat meal, in human volunteers in a randomised, crossover dietary intervention study.
Study design:
Investigators are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tomato sauce (+/- high fat meal) | Active Comparator | 80 gr for 7 days= total load 560 mg (+/- high fat meal) |
|
| diet without tomato (+/- high fat meal) | Placebo Comparator | diet without tomato (+/- high fat meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tomato sauce | Dietary Supplement | We are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study, all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilatation (FMD) | Endothelial function as measured non-invasively by ultrasound (LogiQ P5 pro, GE Healthcare) using the "Flow Mediated Dilatation" (FMD) technique with the aid of a dedicated hardware (Multimedia Video Engine II (MVE2) DSP Lab., Pisa CNR, Italy). | change in FMD 2 and 3.5 hour after a high fat meal |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness measured as Stiffness Index (SI), Carotid distensibility (CD) | systemic and local arterial stiffness measured by digital photoplethysmography (PulseTracePT1000 - MicroMedical Ltd) and by carotid ultrasound (LogiQ P5 pro, GE Healthcare) with the aid of a dedicated hardware (Multimedia Video Engine II (MVE2) DSP Lab., Pisa CNR, Italy). | change in SI and CD 2 and 3.5 hour after a high fat meal |
| Measure | Description | Time Frame |
|---|---|---|
| plasma level of lycopene and other substances contained in tomatoes. | change 2 and 3.5 hour after a high fat meal | |
| glucose and lipid | glucose and lipid variation | change 2 and 3.5 hour after a high fat meal |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiano Fava, M.D.; PhD | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Verona | Verona | 37134 | Italy |
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| inflammatory cytokines | chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal |
| blood pressure | office blood pressure measured by a semiautomatic oscillometric device (TM-2501, A&D instruments Ltd) | change in blood pressure 2 and 3.5 hour after a high fat mealeal |