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

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: tomato sauce

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • University of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tomato sauce (+/- high fat meal); 80 gr for 7 days= total load 560 mg (+/- high fat meal)	Dietary supplement: tomato 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).
Placebo Comparator: diet without tomato (+/- high fat meal)	Dietary supplement: tomato 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Cristiano Fava, M.D.; PhD, Universita di Verona

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: arterial stiffness; lycopene; tomato; flow mediated vasodilatation
• Other Study ID Numbers: VRPM_Tomato_and_endothelium