Sofrito bioactive compounds. Metabolomic study and involved mechanisms on control of oxidative stress and inflammation

Clinical effects of sofrito bioactive compounds in healthy and young subjects after a low antioxidants and a high antioxidants diets: A crossover randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17867378

Enrollment

Registered

2016-07-06

Start date

2016-02-08

Completion date

Unknown

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Not Applicable

Interventions

Each participant is randomly allocated to one of three arms. Those in Arm A consume a diet high in antioxidants (a dish called Sofrito) for two weeks. Those in Arm B consume a diet low in antioxidan

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers 2. Males 3. Age 18-32 years

Exclusion criteria

Exclusion criteria: 1. Previous history of cardiovascular disease (ischemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease) 2. Homeostatic disorders 3. Any several chronic diseases 4. Hypertension or dyslipidemia 5. Tomato intolerance or allergic or onion or garlic intolerance or allergic 6. Smoking subjects 7. Alcoholism 8. Other toxic abuse

Design outcomes

Primary

Measure	Time frame
1. Determination and quantification of carotenoids in plasma by HPLC-DAD at 0h, 5h and 24h 2. Bioavailability, identification and quantification of polyphenols in plasma and urine, assessed using LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS to study the pharmacokinetics parameters at all times between 0 and 24h.	—

Secondary

Measure	Time frame
1. All participants in the study will be clinically examined and subsequently signed an informed consent according to accept their participation in the study 2. At the beginning and end of each intervention period a medical assessment will be performed which includes: clinical history, dietary evaluation, anthropometric measures, clinical blood pressure and 24-hour ambulatory blood pressure and the collection of 24-h urine sample 3. A 1-day and 3-day food record validated nutritional questionnaire will be used at the beginning and end of the intervention to assess nutrient intake and to monitor adherence to the dietary recommendations. We will use the Programa de Càlcul Nutricional Professional (PCN Pro 1.0.32). Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain	—

Measure

Time frame

1. All participants in the study will be clinically examined and subsequently signed an informed consent according to accept their participation in the study 2. At the beginning and end of each intervention period a medical assessment will be performed which includes: clinical history, dietary evaluation, anthropometric measures, clinical blood pressure and 24-hour ambulatory blood pressure and the collection of 24-h urine sample 3. A 1-day and 3-day food record validated nutritional questionnaire will be used at the beginning and end of the intervention to assess nutrient intake and to monitor adherence to the dietary recommendations. We will use the Programa de Càlcul Nutricional Professional (PCN Pro 1.0.32). Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain

—

Countries

Spain

Contacts

Public ContactRosa Mª Lamuela-Raventós

lamuela@ub.edu+34934034843

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026