Plain English Summary
Background and study aims
Organic foods are becoming more popular, and are advertised for their benefits to health and the environment. During their production, organic foods are treated more naturally, without the use of additives and chemicals. Some research has found that organic foods contain higher levels of antioxidants, which is thought to be due to the absence of pesticides. More research about the health benefits of organic foods is necessary however. The aim of this study is to investigate the health benefits to the body of eating a healthy, organic diet compared to a healthy, conventional diet.
Who can participate?
Healthy men and women aged between 18 and 40 years..
What does the study involve?
Participants are randomly allocated into one of two groups. For 28 days, those in the first group follow a healthy and organic diet and those in the second group follow a healthy and conventional diet. After this, the two groups swap so they are following the other diet for a further 28 days. At the beginning and end of each diet, participants provide blood, urine, stool and saliva samples. In addition, all participants undergo a medical assessment at the start and end of the study, which includes having their medical history taken, having their diet and physical activity levels recorded, undergoing a range of anthropometric (body) measurements and having their blood pressure tested as well as providing a urine sample.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants.
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?
June 2016 to December 2016
Who is funding the study?
1. Government of Catalunya (Spain)
2. Biomedical Research Centre in Physiopathology of Obesity and Nutrition (Spain)
Dr Rosa M. Lamuela-Raventós
53 05012 2016
Clinical effects of bioactive compounds from an organic vs. conventional diets (typical Mediterranean diet) in healthy and young subjects: A crossover randomized trial
Organic food has more health benefits to the organism than conventional food.
University of Barcelona. Jordi Alberch Viè, 12/04/2016, ref: IRB00003099
Open controlled randomised cross over trial
Primary study design
Secondary study design
Randomised cross over trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet in Spanish
Participants are randomised to one of two groups who consume each of the two study diets in a random order. There is a 1.5 month wash-out period between the two dietary interventions during which participants can consume their usual diets.
Intervention A: Participants consume a healthy and organic diet for 28 days
Intervention B: Participants consume a healthy and conventional diet for 28 days
Both interventions follow a very similar dietetic pattern, a healthy diet (typical Mediterranean diet) rich in vegetables foods.
Biological samples (blood, urine, stool and saliva) will be taken at the beginning and end of each intervention (baseline and 28 days). The urine recollection will be for 24 hours before of the test. The blood will be centrifuged and all the samples will be stored at -80ºC until analysis.
Primary outcome measures
1. Carotenoids in plasma and saliva is measured using HPLC-DAD at the start and end of each of the 28 day intervention periods
2. Bioavailability, identification and quantification polyphenols in stools, plasma, urine and saliva are assessed using LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS at the start and end of each of the 28 day intervention periods
3. Pesticides in plasma are measured using GC-MS at the start and end of each of the 28 day intervention periods
Secondary outcome measures
1. Adherence to the Mediterranean diet is measured using a questionnaire designed for the purpose of this study at the start and end of each of the 28 day intervention periods
2. Food intake is measured using food frequency questionnaires designed for the purpose of this study at the start and end of each of the 28 day intervention periods
3. Physical activity is evaluated with the Minnesota Leisure Time Physical Activity questionnaire at the start and end of each of the 28 day intervention periods
4. Urine metabolites (metabolomics) are assessed using LTQ-Orbitrap Mass Spectrometry at the start and end of each of the 28 day intervention periods
5. Markers of inflammation are measured by inmunnoassay on plasma samples at the start and end of each of the 28 day intervention periods
6. Constituency of gut microbiota is measured using LTQ-Orbitrap Mass Spectrometry on stool samples at the start and end of each of the 28 day intervention periods
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Healthy volunteers
2. Males and females
3. Age: 18-40
Target number of participants
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. Study’s foods intolerance or allergic
6. Smoking subjects
8. Other toxic abuse
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Food and Nutrition Torribera Campus University of Barcelona. Department of Nutrition, Food Science and Gastronomy.
Prat de la Riba, 171
Santa Coloma de Gramenet (Barcelona)
Veritas (Ecoveritas S.A.)
Carrer de la Diputació
+34 934 617 745
Conservas Monjardín (Conservas José Salcedo Soria S.L.)
Polígono Industrial. Apdo. nº 98
San Adrián (Navarra)
+34 948 672 040
Paul & Pippa Gourmet Food S.L.
C/ Ferro 25
+34 932 061 510
Organic Gourmet (Artfood S.L.)
Carrer de Pujades
+34 931 925 569
Finca Can Feixes
Cabrera d'Anoia (Barcelona)
+34 937 718 227
Raimat (Grupo Codorniu)
Apartat de correus 200
Esplugues de Llobregat (Barcelona)
+34 935 051 551
Aceites Borges Pont S.A.
+34 973 501 212
Olicatessen (Molí dels Torms, SL)
C. Mestre Benet
Els Torms (Lleida)
+34 973 128 362
Government of Catalonia (Generalitat de Catalunya)
Funding Body Type
Funding Body Subtype
Biomedical Research Centre in Physiopathology of Obesity and Nutrition, CIBEROBN
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting