Endothelial Dysfunction
Conditions
Keywords
flow mediated vasodilatation, tomato, arterial stiffness, lycopene
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTtomato sauce
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).
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men, * without overt risk factors for CVD (see
Exclusion criteria
); * age range 28 ±10 years; * BMI between 19-27 Kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilatation (FMD) | change in FMD 2 and 3.5 hour after a high fat meal | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial stiffness measured as Stiffness Index (SI), Carotid distensibility (CD) | change in SI and CD 2 and 3.5 hour after a high fat meal | 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). |
| inflammatory cytokines | chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal | — |
| blood pressure | change in blood pressure 2 and 3.5 hour after a high fat mealeal | office blood pressure measured by a semiautomatic oscillometric device (TM-2501, A&D instruments Ltd) |
Other
| Measure | Time frame | Description |
|---|---|---|
| plasma level of lycopene and other substances contained in tomatoes. | change 2 and 3.5 hour after a high fat meal | — |
| glucose and lipid | change 2 and 3.5 hour after a high fat meal | glucose and lipid variation |
Countries
Italy
Outcome results
None listed