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 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
10/01/2016
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
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
Total final enrolment
11
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
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, MEC
Funding Body Type
government organisation
Funding Body Subtype
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
To be made available at a later date
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29920085 (added 14/06/2019)