Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity
Condition: Dietary Exposure
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      The study is a prospective, controlled, randomized two-arm longitudinal crossover trial,
      performed in a single-centre. Hence, the investigators designed a clinical study aimed to
      investigate the effects of a daily intake of soffritto in overweight or obese class-1
      individuals without other cardiovascular risk. After a run-in period of two-week,
      participants were randomly separated in two different intervention sequences (two-arms) of
      six-weeks in which volunteers were administered with a soffritto (100 g/day) or a control
      group (without soffritto). After the first six-week period, participants had a wash-out phase
      of two-week followed by a second six-week period in which groups exchanged their
      interventions. During the duration of the study, the volunteers were asked to maintain their
      usual diet, excluding raw or cooked tomatoes, as well as tomato-based products (sauces,
      ketchup, juices, etc.) other than those administered during the study in the corresponding
      periods.
    

Detailed description: 
      Sample size (N= 40) was calculated according results of previous studies on pigs
      (http://dx.doi.org/10.1016/j.trsl.2014.11.004). The study refers to healthy adult men (n=27)
      and women (n=13) with ages ranging from 25 to 60 years, non-smokers and with overweight (BMI:
      25.0-29.9 kg/m2) or obesity class 1 (BMI: 30-34.9 kg/m2).

      This study received approval from the Human Ethical Review Committee of Hospital Santa Creu I
      Sant Pau (Barcelona), with the reference number 12/181 and the date of approval being January
      11, 2013. To confirm health status, all subjects underwent a complete physical examination
      conducted by the study physician.

      The study lasted 16 weeks that were structured in:

        -  2 weeks of run-in.

        -  6 weeks of intervention period. During the intervention period, volunteers were
           administered with soffritto (100 g/day) or a control group (without soffritto).

        -  2 weeks of wash-out.

        -  6 weeks of intervention period. During the intervention period, volunteers exchanged
           their interventions

      The volunteers visited the center at days 0, 14, 56, 70 and at the end of the intervention
      period (day 112).

      Dietary habits were collected. Compliance was monitored by weekly telephone contact with
      participants and interviewing them at the end of each intervention period. Blood samples were
      collected early at the morning after twelve-hour fasting at baseline and at the end of each
      intervention phase. Blood samples were used for determining all variables of the study. Stool
      samples were obtained at baseline and after 42 days intervention for the study of platelet
      aggregation, lipid profile, biochemical measurements, vascular endothelial function and
      hemogram profile.
    

Intervention name(s): Soffritto
Intervention type(s): Other
Intervention description(s): The intervention trial was a single-center, prospective, controlled, randomized two-arm longitudinal crossover trial lasting 16 weeks. This duration encompassed a 2-week run-in period, a 6-week intervention period (either in the soffito or control group), a 2-week wash-out period, and another 6-week intervention period (soffritto or control group).
Other intervention name(s): Tomato based products
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The intervention trial consisted of a single-center, prospective, controlled, randomized two-arm longitudinal crossover trial with a total duration of 16 weeks, which includes 2-weeks run-in period, 6 week intervention period (soffito or control group), 2-weeks wash-out period and 6 week intervention period (soffito or control group).
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dietary antiplatelet; Lipid profile; Endothelial activation; Cardiovascular disease