Clinical trial NCT06161883: Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity
Official title: Effect of the Intake of a Tomato Sofrito Preparation on Biomarkers of Cardiovascular Disease in an Overweight and/or Obese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Keywords: Dietary antiplatelet
Lipid profile
Endothelial activation
Cardiovascular disease
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: 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
timeFrame: At days 0 and 42
Secondary outcomes:
measure: Changes from baseline of glucose levels at day 42
timeFrame: At days 0 and 42
measure: 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
timeFrame: At days 0 and 42
measure: Changes from baseline of vascular endothelial function (RHI, lnRHI, FRHI and AI@75) at day 42
timeFrame: At days 0 and 42
measure: Changes from baseline of hemogram profile at day 42
timeFrame: At days 0 and 42
measure: Changes from baseline of hemodynamic profile at day 42
timeFrame: At days 0 and 42
measure: Changes from baseline of hepatic enzymes (ALT, AST and GGT) at day 42
timeFrame: At days 0 and 42
measure: Changes from baseline of renal markers (creatinine, urea and uric acid) at day 42
timeFrame: At days 0 and 42
measure: Changes from baseline of BMI at day 42
timeFrame: At days 0 and 42
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Recerca-Hospital Santa Creu I Sant Pau
Study officials:
References: