Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects
Condition: Endothelial Dysfunction
Study type: Interventional

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).
    

Intervention name(s): tomato sauce
Intervention type(s): Dietary Supplement
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: flow mediated vasodilatation; tomato; arterial stiffness; lycopene