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Completed

NCT Number: NCT06161883

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

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.

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Key information

Conditions

Dietary Exposure Cardiovascular Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Recerca-Hospital Santa Creu I Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Tomato based products

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

    Time frame: At days 0 and 42

    By the light transmission technique LTA. For all agonist results were expressed as the percentage of variation respect to the baseline value (100%).

Secondary outcomes

  1. Changes from baseline of glucose levels at day 42

    Time frame: At days 0 and 42

    Using routine commercially available assays

  2. 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

    Time frame: At days 0 and 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

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

    Time frame: At days 0 and 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

  4. Changes from baseline of hemogram profile at day 42

    Time frame: At days 0 and 42

    Digital plethysmography using the EndoPAT2000-device

  5. Changes from baseline of hemodynamic profile at day 42

    Time frame: At days 0 and 42

    Blood pressure monitor (Sphygmomanometer)

  6. Changes from baseline of hepatic enzymes (ALT, AST and GGT) at day 42

    Time frame: At days 0 and 42

    Using routine commercially available assays

  7. Changes from baseline of renal markers (creatinine, urea and uric acid) at day 42

    Time frame: At days 0 and 42

    Using routine commercially available assays

  8. Changes from baseline of BMI at day 42

    Time frame: At days 0 and 42

    Dividing the body weight in kilograms by the square of height in meters (kg/m2)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: FRITOCARD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 8, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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