Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity (FRITOCARD)

Effect of the Intake of a Tomato Sofrito Preparation on Biomarkers of Cardiovascular Disease in an Overweight and/or Obese Population

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.

Study Overview

• Status: Completed
• Conditions: Dietary Exposure
• Intervention / Treatment: Other: Soffritto

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Institut Recerca-Hospital Santa Creu I Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and Women 25-60 years of age
• BMI: >28 Kg/m2

Exclusion Criteria:

• Ischemic heart disease (and/or previous angina or AMI)
• Less than 25 years old and more than 60 years old
• Current/previous history of arrhythmia
• Cardiovascular co-morbidity (previous cardiovascular accidents and/or peripheral vascular disease)
• On current treatment with vasoactive drugs, fibrates or statins (see exception)
• Alcohol consumption of more than 60 gr/day
• Renal insufficiency (creatinine > 2 mg/dl)
• Presence of neoplasia
• Presence of systemic disease
• Psychiatric disease in treatment with psychotropic drugs
• Secondary dyslipidemia (nephrotic syndrome, hypothyroidism, others...)
• Being in a weight loss phase or expressing a desire for weight loss during the 3 months of the study duration.
• Having taken aspirin in the 10-day period prior to blood sampling.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soffritto group; After a two-week run-in phase, participants (N=20) were randomly assigned to the Soffritto group. For 6 weeks, volunteers received soffritto (100 g/day). After the initial six-week phase, there was a two-week washout period, followed by a second six-week period in which participants were placed in the control group.	Other: Soffritto; 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 Names: Tomato based products
Experimental: Control group; After a two-week run-in phase, the participants (N=20) were randomly assigned to the control group. For 6 weeks, the volunteers did not receive any product. After the initial six-week run-in phase, there was a two-week washout period, followed by a second six-week period in which participants were switched to the Soffritto group (100g/day).	Other: Soffritto; 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 Names: Tomato based products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline of platelet aggregation (induced by different agonists: arachidonic acid [1 mM], collagen [2 and 5 µM] and ADP [5 and 20 µM] at day 42	By the light transmission technique LTA. For all agonist results were expressed as the percentage of variation respect to the baseline value (100%).	At days 0 and 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline of glucose levels at day 42	Using routine commercially available assays	At days 0 and 42
Changes from baseline of standard serum lipid profile (total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol and triacylglycerols expressed as mg/dL) at day 42	Routine commercially available assays were used for triglycerides, total cholesterol and high density lipoprotein cholesterol. Low density lipoprotein cholesterol was calculated using the Friedewald equation	At days 0 and 42
Changes from baseline of vascular endothelial function (RHI, lnRHI, FRHI and AI@75) at day 42	Digital plethysmography using the EndoPAT2000-device. Endothelial function was given as the reactive hyperaemia index (RHI) and the arterial stiffness as the augmentation index (AI) and AI standardized to a pulse of 75/min (AI@75). The natural logarithmically transformed RHI (lnRHI) values was also calculated. The Framingham RHI (FRHI) was calculated as the natural log-transformation of the RHI	At days 0 and 42
Changes from baseline of hemogram profile at day 42	Digital plethysmography using the EndoPAT2000-device	At days 0 and 42
Changes from baseline of hemodynamic profile at day 42	Blood pressure monitor (Sphygmomanometer)	At days 0 and 42
Changes from baseline of hepatic enzymes (ALT, AST and GGT) at day 42	Using routine commercially available assays	At days 0 and 42
Changes from baseline of renal markers (creatinine, urea and uric acid) at day 42	Using routine commercially available assays	At days 0 and 42
Changes from baseline of BMI at day 42	Dividing the body weight in kilograms by the square of height in meters (kg/m2)	At days 0 and 42

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2013
• Primary Completion (Actual): February 28, 2014
• Study Completion (Actual): February 28, 2014

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Lipid profile; Endothelial activation; Dietary antiplatelet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Cardiovascular Diseases; Overweight
• Other Study ID Numbers: ICCC-10 FRITOCARD; CEN-20101016 (Other Grant/Funding Number: CDTI-Spanish Ministry of Competitivity and Economy (MINECO))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No