Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161883
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-11-20
Brief Title:
Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Effect of the Intake of a Tomato Sofrito Preparation on Biomarkers of Cardiovascular Disease in an Overweight andor Obese Population
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRITOCARD
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 gday 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 httpdxdoiorg101016jtrsl201411004 The study refers to healthy adult men n27 and women n13 with ages ranging from 25 to 60 years non-smokers and with overweight BMI 250-299 kgm2 or obesity class 1 BMI 30-349 kgm2
This study received approval from the Human Ethical Review Committee of Hospital Santa Creu I Sant Pau Barcelona with the reference number 12181 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 gday 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
This study received approval from the Human Ethical Review Committee of Hospital Santa Creu I Sant Pau Barcelona with the reference number 12181 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 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CEN-20101016 | OTHER_GRANT | CDTI-Spanish Ministry of Competitivity and Economy MINECO | None |