Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Legumes (e.g., (lentils, chickpeas, white beans) are nutrient-rich foods that as part of healthy diet have been found to improve glycaemic (blood sugar) control and weight management, as well as to reduce blood pressure and cholesterol levels. Therefore, there is a growing interest to assess the association between eating legumes and the risk of develop chronic (long-term) diseases. An accurate assessment of legumes consumption by testing the levels of substances called biomarkers in biological fluids (e.g., blood, urine) is key to understanding these relationships. The aim of this study is to find new biomarkers of legumes intake.

Who can participate?
Healthy non-smoking adults, between 18 and 40 years of age, not taking any regular medication or supplements, without any chronic or infectious disease, and free of allergy, intolerance or aversion to legumes.

What does the study involve?
Each participant is randomly allocated to eat one of four different foods (lentils, chickpeas, white beans or pasta). Blood and urine samples are taken, and then a large portion of one of the foods is given to each participant. Blood samples are taken up to 6 hours after eating each food, as well as 24 and 48 hours later. Urine samples are also collected at different intervals during the 48 hours after eating each food. After this, participants attend three further study visits, repeating the procedure with the other three foods.

What are the possible benefits and risks of participating?
There are no direct benefits to participants, other than having a health check as part of the screening. There are no notable risks of taking part. However, there is a small risk of bruising when giving a blood sample, but this is reduced by the use of experienced nursing staff.

Where is the study run from?
University of Barcelona (Spain)

When is the study starting and how long is it expected to run for?
January 2016 to December 2018

Who is funding the study?
1. Joint Programming Initiative (JPI-HDHL, EU)
2. Ministry of Economy and Competitiveness (MINECO, Spain)
3. University of Barcelona (UB, Spain)

Who is the main contact?
Dr Cristina Andres-Lacueva

Trial website

Contact information



Primary contact

Dr Cristina Andres-Lacueva


Contact details

Biomarkers and Nutritional & Food Metabolomics Research Group
Department of Nutrition
Food Science and Gastronomy
Faculty of Pharmacy and Food Science
University of Barcelona
Av Joan XXIII s/n

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Discovery of novel biomarkers of legumes intake using a metabolomics based approach


Study hypothesis

Following an intake of legumes, metabolites related to their nutritional composition will increase in urine and blood. The potential of these metabolites as candidate biomarkers of legumes intake will be evaluated.

Ethics approval

Bioethical Committee of the University of Barcelona, 17/11/2015, ref: IRB00003099.

Study design

Randomized cross-over trial

Primary study design


Secondary study design

Randomised cross over trial

Trial setting


Trial type


Patient information sheet

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


Biomarkers of food intake


Volunteers will consume one of the following foods in a random order: lentils, chickpeas, white beans and pasta. These foods will be consumed on separate study visits, and baseline and postpandrial blood samples will be taken up to 6 hours following consumption, as well as a fasting blood sample 24 and 48 hours after the intake of each food. Urine samples will be also collected at baseline and at different intervals during the 48 hours post-consumption of each food.

Intervention type



Drug names

Primary outcome measure

Presence of biomarkers of legumes consumption in blood and urine, measured using an untargeted metabolomics approach. Fasting blood and urine samples are collected before the intake of each food. Then, postpandrial blood samples are taken after 1, 2, 4 and 6h; and additional fasting blood samples 24 and 48 hours after the intake of each food. In parallel, urine samples are also collected in the following intervals post-consumption of each food: 0-1h, 1-2h, 2-4h, 4-6h, 6-12h, 12-24h, 24-48h.

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Healthy adults aged between 18 and 40 years old
2. Non-smokers
3. BMI >18.5 or < 30 kg/m2
4. Weight >55 kg
5. Free of chronic or infectious disease
6. Not pregnant, planning a pregnancy or lactating
7. Not taking any regular medication (oral contraceptive pill is allowed)
8. Not taking supplements
9. No antibiotics in the 6 previous months
10. No allergy or aversion to legumes or pasta
11. Not anaemic
12. No blood donation within the last 2 months

Participant type

Healthy volunteer

Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Smokers
2. Diagnosed anaemia or another health condition (chronic or infectious disease)
3. Blood donation during the previous 2 months
4. Allergy, intolerance or aversion to legumes or pasta
5. Taking medication or supplements (oral contraceptive pill is allowed)
6. Pregnant, planning a pregnancy or lactating

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Nutrition, Food Science and Gastronomy
Faculty of Pharmacy and Food Science University of Barcelona Av. Joan XXIII, s/n

Sponsor information


University of Barcelona

Sponsor details

Biomarkers and Nutritional & Food Metabolomics Research Group
Department of Nutrition
Food Science and Gastronomy
Faculty of Pharmacy and Food Science
University of Barcelona
Av. Joan XXIII

Sponsor type




Funder type


Funder name

Joint Programming Initiative - Healthy Diet for Healthy Lifestyle (JPI-HDHL)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Ministerio de Economía y Competitividad

Alternative name(s)

Ministry of Economy and Competitiveness, MINECO, MEC

Funding Body Type

government organisation

Funding Body Subtype

National government



Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal

IPD sharing plan
The current data sharing plans for the study are unknown and will be made available at a later date

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 results in: (added 14/06/2019)

Publication citations

Additional files

Editorial Notes

14/06/2019: Publication reference and total final enrolment number added.