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

NCT ID: NCT06161883

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-15
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Dietary Exposure

Keywords

Dietary antiplatelet; Lipid profile; Endothelial activation; Cardiovascular disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Soffritto

Intervention Type: OTHER

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).

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).

Group Type: EXPERIMENTAL

Soffritto

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

Tomato based products

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Recerca-Hospital Santa Creu I Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

CEN-20101016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ICCC-10 FRITOCARD

Identifier Type: -

Identifier Source: org_study_id