Dietary ExposureFRITOCARDNCT06161883
Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity
A study testing Soffritto in people with Dietary Exposure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Soffritto
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2013to 28 Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and Women 25-60 years of age
- BMI: >28 Kg/m2
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Soffritto
- Keywords
- Dietary antiplatelet, Lipid profile, Endothelial activation, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoffrittoOther
Also called Tomato based products
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Soffritto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: At days 0 and 42
Secondary outcomes (8)
Changes from baseline of glucose levels at day 42
Using routine commercially available assays
Measured: 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
Measured: 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
Measured: At days 0 and 42
Changes from baseline of hemogram profile at day 42
Digital plethysmography using the EndoPAT2000-device
Measured: At days 0 and 42
Changes from baseline of hemodynamic profile at day 42
Blood pressure monitor (Sphygmomanometer)
Measured: At days 0 and 42
Changes from baseline of hepatic enzymes (ALT, AST and GGT) at day 42
Using routine commercially available assays
Measured: At days 0 and 42
Changes from baseline of renal markers (creatinine, urea and uric acid) at day 42
Using routine commercially available assays
Measured: 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)
Measured: At days 0 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Mar 2013
- Primary completion28 Feb 2014
- Study completion28 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161883
- Sponsor's protocol ID
- ICCC-10 FRITOCARD
- Other IDs
- CEN-20101016
- Acronym
- FRITOCARD
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Intake of a Tomato Sofrito Preparation on Biomarkers of Cardiovascular Disease in an Overweight and/or Obese Population
- ClinicalTrials.gov ID
- NCT06161883
- Acronym / sponsor ID
- FRITOCARD / ICCC-10 FRITOCARD
- Conditions
- Dietary Exposure
- Keywords
- Dietary antiplatelet, Lipid profile, Endothelial activation, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 15 Mar 2013 (actual)
- Primary completion
- 28 Feb 2014 (actual)
- Study completion
- 28 Feb 2014 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Soffritto group | Experimental | Other: SoffrittoAfter 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. |
| Control group | Experimental | Other: SoffrittoAfter 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). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and Women 25-60 years of age
- BMI: >28 Kg/m2
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoffrittoAlso: Tomato based productsThe 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 | Control group, Soffritto group |
Primary outcome
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%).
8 secondary outcomes
Changes from baseline of glucose levels at day 42
Time frame: 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
Time frame: At days 0 and 42
Changes from baseline of vascular endothelial function (RHI, lnRHI, FRHI and AI@75) at day 42
Time frame: At days 0 and 42
Changes from baseline of hemogram profile at day 42
Time frame: At days 0 and 42
Changes from baseline of hemodynamic profile at day 42
Time frame: At days 0 and 42
Changes from baseline of hepatic enzymes (ALT, AST and GGT) at day 42
Time frame: At days 0 and 42
Changes from baseline of renal markers (creatinine, urea and uric acid) at day 42
Time frame: At days 0 and 42
Changes from baseline of BMI at day 42
Time frame: At days 0 and 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soffritto in people with Dietary Exposure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At days 0 and 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.