Demonstration of the nutritional benefits of following an organic vs. conventional diets using “omics technologies”

ISRCTN	ISRCTN29145931
DOI	https://doi.org/10.1186/ISRCTN29145931
Secondary identifying numbers	53 05012 2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Rosa M Lamuela-Raventos
Public

University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain

ORCID ID	0000-0002-1287-4560
Phone	+34 934 034 843
Email	lamuela@ub.edu

Study information

Study design	Open controlled randomised cross over trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet in Spanish
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	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 study start date	16/05/2016
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	Both
Target number of participants	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

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)
08921
Spain

Sponsor information

Veritas (Ecoveritas S.A.)
Industry

Carrer de la Diputació, 239
Barcelona
08007
Spain

Phone	+34 934 617 745
Email	evillamayor@ecoveritas.es
Website	www.veritas.es/

Conservas Monjardín (Conservas José Salcedo Soria S.L.)
Industry

Polígono Industrial. Apdo. nº 98
San Adrián (Navarra)
31570
Spain

Phone	+34 948 672 040
Email	info@monjardinorganic.com
Website	www.monjardinorganic.com/

Paul & Pippa Gourmet Food S.L.
Industry

C/ Ferro 25, nave N.
Barcelona
08038
Spain

Phone	+34 932 061 510
Email	info@paulandpippa.com

Organic Gourmet (Artfood S.L.)
Industry

Carrer de Pujades, 74
Barcelona
08005
Spain

Phone	+34 931 925 569
Email	iarteaga@organicgourmetbcn.com
Website	www.organicgourmetbcn.com/

Can Feixes
Industry

Finca Can Feixes
Cabrera d'Anoia (Barcelona)
08718
Spain

Phone	+34 937 718 227
Email	canfeixes@canfeixes.com
Website	www.canfeixes.com/

Raimat (Grupo Codorniu)
Industry

Apartat de correus 200
Esplugues de Llobregat (Barcelona)
08950
Spain

Phone	+34 935 051 551
Email	info@raimat.es
Website	www.codorniuraventos.com/es/bodegas/raimat

Aceites Borges Pont S.A.
Industry

Josep Trepat, s/n
Tàrrega (Lleida)
25300
Spain

Phone	+34 973 501 212
Email	abp@borges.es
Website	www.borges.es

Olicatessen (Molí dels Torms, SL)
Industry

C. Mestre Benet, 19
Els Torms (Lleida)
25164
Spain

Phone	+34 973 128 362
Email	info@olicatessen.com
Website	www.olicatessen.com/

Funders

Funder type

Government

Government of Catalonia (Generalitat de Catalunya)

No information available

Biomedical Research Centre in Physiopathology of Obesity and Nutrition, CIBEROBN

No information available

Results and Publications

Intention to publish date	28/02/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
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

Editorial Notes

20/01/2023: Publication reference added.