Demonstration of the nutritional benefits of following an organic vs. conventional diets using “omics technologies”
| ISRCTN | ISRCTN29145931 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29145931 |
| Protocol serial number | 53 05012 2016 |
| Sponsors | Veritas (Ecoveritas S.A.), Conservas Monjardín (Conservas José Salcedo Soria S.L.), Paul & Pippa Gourmet Food S.L., Organic Gourmet (Artfood S.L.), Can Feixes, Raimat (Grupo Codorniu), Aceites Borges Pont S.A., Olicatessen (Molí dels Torms, SL) |
| Funders | Government of Catalonia (Generalitat de Catalunya), Biomedical Research Centre in Physiopathology of Obesity and Nutrition, CIBEROBN |
- Submission date
- 26/10/2016
- Registration date
- 16/12/2016
- Last edited
- 20/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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)
Main contact
Dr Rosa M. Lamuela-Raventós
Contact information
Public
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain
 ORCID ID |
0000-0002-1287-4560 |
|---|---|
| Phone | +34 934 034 843 |
| lamuela@ub.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open controlled randomised cross over trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Clinical effects of bioactive compounds from an organic vs. conventional diets (typical Mediterranean diet) in healthy and young subjects: A crossover randomized trial |
| Study acronym | ECOCONDIET |
| Study objectives | Organic food has more health benefits to the organism than conventional food. |
| Ethics approval(s) | University of Barcelona. Jordi Alberch Viè, 12/04/2016, ref: IRB00003099 |
| Health condition(s) or problem(s) studied | Diet |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Carotenoids in plasma and saliva is measured using HPLC-DAD at the start and end of each of the 28 day intervention periods |
| Key secondary outcome measure(s) |
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 |
| Completion date | 21/03/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | All |
| Target sample size at registration | 25 |
| Key inclusion criteria | 1. Healthy volunteers 2. Males and females 3. Age: 18-40 |
| 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. Study’s foods intolerance or allergic 6. Smoking subjects 7. Alcoholism 8. Other toxic abuse |
| Date of first enrolment | 20/06/2016 |
| Date of final enrolment | 23/01/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Santa Coloma de Gramenet (Barcelona)
08921
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/08/2019 | 20/01/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/01/2023: Publication reference added.
