Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/02/2017
Date assigned
28/02/2017
Last edited
28/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Type

Scientific

Primary contact

Dr Cristina Andres-Lacueva

ORCID ID

http://orcid.org/0000-0002-8494-4978

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
Barcelona
08028
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Biomarkers of food intake

Intervention

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

Other

Phase

Drug names

Primary outcome measures

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

10/01/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

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

Adult

Gender

Both

Target number of participants

12

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

10/01/2016

Recruitment end date

30/06/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Department of Nutrition, Food Science and Gastronomy
Faculty of Pharmacy and Food Science University of Barcelona Av. Joan XXIII, s/n
Barcelona
08028
Spain

Sponsor information

Organisation

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
s/n
Barcelona
08028
Spain

Sponsor type

University/education

Website

http://nutrimetabolomics.com/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministerio de Economía y Competitividad

Alternative name(s)

Ministry of Economy and Competitiveness, MINECO

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

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

31/12/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes