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

ISRCTN	ISRCTN17867378
DOI	https://doi.org/10.1186/ISRCTN17867378
Secondary identifying numbers	AGL2013-49083-C3-1-R

Submission date: 02/06/2016
Registration date: 06/07/2016
Last edited: 18/08/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Antioxidants are substances that may prevent or delay damage to the cells in our bodies by mechanisms such as decrease oxidative stress and inflammation. They are found in many foods, mainly fruit and vegetables. Among them, polyphenols and carotenoids are antioxidants in typical foods like a sofrito. Sofrito is a tomato sauce that contains oil, onion and garlic. The aim of this study is to compare the pharmacokinetics parameters of sofrito bioactive compounds in a group with a previous consumption of a low antioxidant diet for 10 days versus the same group after a high antioxidant diet

Who can participate?
Healthy men between 18 and 32 years of age without a history of cardiovascular disease, any of several chronic diseases or an allergy/intolerance compounds of sofrito, not smoking neither any toxic practice.

What does the study involve?
Each participant is randomly allocated to one of three arms. Those in Arm A eat a diet high in antioxidants for two weeks. Those in Arm B eat a diet low in antioxidants for 2 weeks. Those in Arm 3 (the control arm) eat their normal diet. As it’s a crossover study, all participants are eventually allocated to all three arms, one at a time, but in a random order with a “rest” (or washout) period of two weeks between each arm. Participants eat their usual diet during the washout period. All participants have a medical assessment at the start and end of the study, which includes looking at their clinical history and what they eat, their body measurements, blood pressure and the collection of a 24-hour urine sample. In addition to this, all participants are asked to eat 240 g of a dish called sofrito/ 70kg, and are asked not eat tomato or onion. Additional blood samples and urine samples are then taken from each participant for analyses.

What are the possible benefits and risks of participating?
There are no risks as long as the exclusion criteria are followed.

Where is the study run from?
Department of Nutrition, Food Science and Gastronomy of Food and Nutrition Torribera Campus University of Barcelona (Spain)

When is the study starting and how long is it expected to run for?
January 2016 to December 2016

Who is funding the study?
1. Ministry of Economy and Competitiveness, MINECO
2. Biomedical Research Centre in Physiopathology of Obesity and Nutrition (CIBEROBN)

Main contact
Dr. Rosa Lamuela-Raventós
lamuela@ub.edu

Contact information

Dr Rosa Mª Lamuela-Raventós
Public

Av/ Joan XXIII S/N
Barcelona
08028
Spain

ORCID ID	0000-0002-1287-4560
Phone	+34934034843
Email	lamuela@ub.edu

Study information

Study design	Open controlled randomized cross over trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Clinical effects of sofrito bioactive compounds in healthy and young subjects after a low antioxidants and a high antioxidants diets: A crossover randomized trial
Study acronym	SOBIOCOM
Study objectives	Sofrito is a high antioxidants food that would be positive in prevention diseases. People who intake a low antioxidants diet have higher bioavailability of antioxidants compounds than people who intake a high antioxidants diet. This hypothesis is based in the body mechanism to maintain levels of antioxidants into physiological range avoiding overloading of these.
Ethics approval(s)	University of Barcelona. Jordi Alberch Viè, 12/04/2016, ref: IRB00003099
Health condition(s) or problem(s) studied	Healthy
Intervention	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 antioxidants for 2 weeks. Those in Arm 3 (the control arm) eat their normal diet. As it’s a crossover study, all participants do all three arms, in a random order with a washout period of two weeks between each arm. Participants consume their usual diet without limitations or specific guidelines during the washout period. All participants have a medical assessment is at the start and end of the study, which includes clinical history, dietary evaluation, anthropometric (body) measures, clinical blood pressure measurement and the collection of a 24-hour urine sample. At the end of each intervention period, every participant consumes 240 g of sofrito/ 70kg, but is not allowed to eat tomato or onion. Additional blood samples and urine samples are then taken from each participant for analyses.
Intervention type	Other
Primary outcome measure	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 outcome measures	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
Overall study start date	18/01/2016
Completion date	23/12/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	32 Years
Sex	Male
Target number of participants	22
Total final enrolment	22
Key inclusion criteria	1. Healthy volunteers 2. Males 3. Age 18-32 years
Key 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
Date of first enrolment	08/02/2016
Date of final enrolment	16/06/2016

Locations

Countries of recruitment

Spain

Study participating centre

Department of Nutrition, Food Science and Gastronomy of Food and Nutrition Torribera Campus (University of Barcelona)

Prat de la Riba, 171
Santa Coloma de Gramenet (Barcelona)
08921
Spain

Sponsor information

Gallina Blanca
Industry

Plaza Europa, 41
Barcelona
08908
Spain

Phone	902 101 50
Email	consulta@gallinablanca.es
Website	https://www.gallinablanca.es

Funders

Funder type

Government

Ministerio de Economía y Competitividad
Government organisation / National government

Alternative name(s): Ministry of Economy and Competitiveness, MINECO, MEC
Location: Spain

Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y Nutrición
Private sector organisation / Research institutes and centers

Alternative name(s): Biomedical Research Center Network on Physiopathology of Obesity and Nutrition, CIBER Physiopathology of Obesity and Nutrition, Centro de Investigacion Biomedica en Red Fisiopatologia de la Obesidad y Nutricion, Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, CIBER de Fisiopatología de la Obesidad y Nutrición, CIBEROBN
Location: Spain

Results and Publications

Intention to publish date	23/12/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/11/2018	29/01/2019	Yes	No
Results article		15/04/2019	18/08/2023	Yes	No

Editorial Notes

18/08/2023: Publication reference and total final enrolment added.
29/01/2019: Publication reference added
12/10/2017: Internal review.