Condition category
Not Applicable
Date applied
02/06/2016
Date assigned
06/07/2016
Last edited
06/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Rosa Mª Lamuela-Raventós

ORCID ID

http://orcid.org/0000-0002-1287-4560

Contact details

Av/ Joan XXIII S/N
Barcelona
08028
Spain
+34934034843
lamuela@ub.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGL2013-49083-C3-1-R

Study information

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

Acronym

SOBIOCOM

Study hypothesis

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

University of Barcelona. Jordi Alberch Viè, 12/04/2016, ref: IRB00003099

Study design

Open controlled randomized cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

18/01/2016

Overall trial end date

23/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

22

Participant 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

Recruitment start date

08/02/2016

Recruitment end date

16/06/2016

Locations

Countries of recruitment

Spain

Trial 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

Organisation

Gallina Blanca

Sponsor details

Plaza Europa
41
Hospitalet de Llobregat (Barcelona)
08908
Spain
902 101 50
consulta@gallinablanca.es

Sponsor type

Industry

Website

www.gallinablanca.es

Funders

Funder type

Government

Funder name

Ministry of Economy and Competitiveness, MINECO

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Biomedical Research Centre in Physiopathology of Obesity and Nutrition, CIBEROBN

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes