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

NCT01968369 | Completed

• 1 other identifier: VRPM_Tomato_and_endothelium
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Keywords

flow mediated vasodilatation; tomato; arterial stiffness; lycopene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• inflammatory cytokines

  chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal

• blood pressure

  change in blood pressure 2 and 3.5 hour after a high fat mealeal

Other Outcomes (2)

• plasma level of lycopene and other substances contained in tomatoes.

  change 2 and 3.5 hour after a high fat meal

• glucose and lipid

  change 2 and 3.5 hour after a high fat meal

Study Arms (2)

tomato sauce (+/- high fat meal)

ACTIVE COMPARATOR

80 gr for 7 days= total load 560 mg (+/- high fat meal)

Dietary Supplement: tomato sauce

diet without tomato (+/- high fat meal)

PLACEBO COMPARATOR

diet without tomato (+/- high fat meal)

Dietary Supplement: tomato sauce

Interventions

tomato sauce DIETARY_SUPPLEMENT

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).

diet without tomato (+/- high fat meal); tomato sauce (+/- high fat meal)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men,

You may not qualify if:

• age range 28 ±10 years;
• BMI between 19-27 Kg/m2
• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, 37134, Italy

Location

Study Officials

• Cristiano Fava, M.D.; PhD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 24, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

IT (1)