ISRCTN - ISRCTN29145931: Demonstration of the nutritional benefits of following an organic vs. conventional diets using “omics technologies”

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)

Main contact
Dr Rosa M. Lamuela-Raventós

Trial website

Contact information

Type

Public

Primary contact

Dr Rosa M Lamuela-Raventos

ORCID ID

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

Contact details

University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain
+34 934 034 843
lamuela@ub.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

53 05012 2016

Study information

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

Acronym

ECOCONDIET

Study hypothesis

Organic food has more health benefits to the organism than conventional food.

Ethics approval

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

Study design

Open controlled randomised cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet in Spanish

Condition

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

Phase

Drug names

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 trial start date

16/05/2016

Overall trial end date

21/03/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy volunteers
2. Males and females
3. Age: 18-40

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

25

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
7. Alcoholism
8. Other toxic abuse

Recruitment start date

20/06/2016

Recruitment end date

23/01/2017

Locations

Countries of recruitment

Spain

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)
08921
Spain

www.olicatessen.com/

Funders

Funder type

Government

Funder name

Government of Catalonia (Generalitat de Catalunya)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Biomedical Research Centre in Physiopathology of Obesity and Nutrition, CIBEROBN