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

NCT06161883 | Completed DMC

• 2 other identifiers: ICCC-10 FRITOCARDCEN-20101016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Exposure

Keywords

Dietary antiplatelet; Lipid profile; Endothelial activation; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes from baseline of glucose levels at day 42

  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

  At days 0 and 42

• Changes from baseline of vascular endothelial function (RHI, lnRHI, FRHI and AI@75) at day 42

  At days 0 and 42

• Changes from baseline of hemogram profile at day 42

  At days 0 and 42

• Changes from baseline of hemodynamic profile at day 42

  At days 0 and 42

Study Arms (2)

Soffritto group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

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

Interventions

Soffritto 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).

Also known as: Tomato based products

Control group; Soffritto group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institut Recerca-Hospital Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 8, 2023
• Study Start: March 15, 2013
• Primary Completion: February 28, 2014
• Study Completion: February 28, 2014
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

ES (1)