Overview

This trial is active, not recruiting.

Condition endothelial dysfunction
Treatment tomato sauce
Sponsor Universita di Verona
Start date October 2013
End date December 2016
Trial size 16 participants
Trial identifier NCT01968369, VRPM_Tomato_and_endothelium

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
80 gr for 7 days= total load 560 mg (+/- high fat meal)
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)
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).

Primary Outcomes

Measure
Flow Mediated Dilatation (FMD)
time frame: 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)
time frame: change in SI and CD 2 and 3.5 hour after a high fat meal
inflammatory cytokines
time frame: chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal
blood pressure
time frame: change in blood pressure 2 and 3.5 hour after a high fat mealeal

Eligibility Criteria

Male participants from 18 years up to 38 years old.

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.

Additional Information

Official title Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects
Principal investigator Cristiano Fava, M.D.; PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universita di Verona.