Status:
COMPLETED
Effect of Tomato Soffritto Intake on Biomarkers of Cardiovascular Disease in an Overweight and Obesity
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Dietary Exposure
Eligibility:
All Genders
25-60 years
Phase:
NA
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 effec...
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...
Eligibility Criteria
Inclusion
- Men and Women 25-60 years of age
- BMI: \>28 Kg/m2
Exclusion
- 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.
Key Trial Info
Start Date :
March 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06161883
Start Date
March 15 2013
End Date
February 28 2014
Last Update
December 8 2023
Active Locations (1)
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1
Institut Recerca-Hospital Santa Creu I Sant Pau
Barcelona, Spain, 08025