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

Not Applicable

Completed

• Conditions: Healthy; Not Applicable

• Registration Number: ISRCTN17867378
• Lead Sponsor: Gallina Blanca

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30441880 results (added 29/01/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30991720/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-06
• Study Completion: 2016-12-23
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Determination and quantification of carotenoids in plasma by HPLC-DAD at 0h, 5h and 24h <br>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 Outcome Measures

Name	Time	Method
1. All participants in the study will be clinically examined and subsequently signed an informed consent according to accept their participation in the study<br>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<br>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