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

Endothelial Dysfunction Clinical Trial

— VRPM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968369
• Other study ID #: VRPM_Tomato_and_endothelium
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2019
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

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).

Locations

Country	Name	City	State
Italy	University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plasma level of lycopene and other substances contained in tomatoes.		change 2 and 3.5 hour after a high fat meal
Other	glucose and lipid	glucose and lipid variation	change 2 and 3.5 hour after a high fat meal
Primary	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	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
Secondary	inflammatory cytokines		chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal
Secondary	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