Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Dietary Supplement: tomato sauce

• Registration Number: NCT01968369
• Lead Sponsor: Universita di Verona

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).

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
diet without tomato (+/- high fat meal)	tomato sauce	diet without tomato (+/- high fat meal)
tomato sauce (+/- high fat meal)	tomato sauce	80 gr for 7 days= total load 560 mg (+/- high fat meal)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
inflammatory cytokines	chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal
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).
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)

Trial Locations

Locations (1)

University of Verona; 🇮🇹 Verona, Italy