Clinical trial NCT01968369: Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects
Official title: Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: flow mediated vasodilatation
tomato
arterial stiffness
lycopene
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* Healthy men,
* without overt risk factors for CVD (see exclusion criteria);
* age range 28 ±10 years;
* BMI between 19-27 Kg/m2

Exclusion Criteria:

* Previous cardiovascular events, kidney failure (serum creatinine ≥1,5 mg/dl), arterial blood pressure ≥140/90mmHg or diagnosed hypertension; chronic inflammatory or neoplastic diseases, diabetes mellitus or impaired fasting glucose (glucose ≥110 mg/dL), hypercholesterolemia (total cholesterol ≥240 mg/dl or anti-lipemic medication use), current smoking, antihypertensive medications; use of antioxidant drugs or NSAIDs or COXIBs; food allergy to tomato or other components of the high fat diet.

Primary outcomes:
measure: Flow Mediated Dilatation (FMD)
timeFrame: change in FMD 2 and 3.5 hour after a high fat meal
Secondary outcomes:
measure: Arterial stiffness measured as Stiffness Index (SI), Carotid distensibility (CD)
timeFrame: change in SI and CD 2 and 3.5 hour after a high fat meal
measure: inflammatory cytokines
timeFrame: chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal
measure: blood pressure
timeFrame: change in blood pressure 2 and 3.5 hour after a high fat mealeal
Other outcomes:
measure: plasma level of lycopene and other substances contained in tomatoes.
timeFrame: change 2 and 3.5 hour after a high fat meal
measure: glucose and lipid
timeFrame: change 2 and 3.5 hour after a high fat meal
Locations:
city: Verona
country: Italy
facility: University of Verona
Study officials:
affiliation: Universita di Verona
name: Cristiano Fava, M.D.; PhD
role: PRINCIPAL_INVESTIGATOR
References: