Discovery of novel biomarkers of legumes intake

ISRCTN	ISRCTN17200423
DOI	https://doi.org/10.1186/ISRCTN17200423
Secondary identifying numbers	N/A

Submission date: 08/02/2017
Registration date: 28/02/2017
Last edited: 04/06/2024

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
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

Contact information

Dr Cristina Andres-Lacueva
Scientific

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

ORCID ID	0000-0002-8494-4978

Study information

Study design	Randomized cross-over trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet in Spanish.
Scientific title	Discovery of novel biomarkers of legumes intake using a metabolomics based approach
Study objectives	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(s)	Bioethical Committee of the University of Barcelona, 17/11/2015, ref: IRB00003099.
Health condition(s) or problem(s) studied	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
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 study start date	10/01/2016
Completion date	31/12/2018

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	12
Total final enrolment	11
Key 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
Key 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
Date of first enrolment	10/01/2016
Date of final enrolment	30/06/2016

Locations

Countries of recruitment

Spain

Study 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

University of Barcelona
University/education

Website	http://nutrimetabolomics.com/
"ROR"	https://ror.org/052g8jq94

Funders

Funder type

Government

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

No information available

Ministerio de Economía y Competitividad
Government organisation / National government

Alternative name(s): Ministry of Economy and Competitiveness, MINECO, MEC
Location: Spain

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/07/2018	14/06/2019	Yes	No
Other publications	Impact of sample treatment	02/06/2023	04/06/2024	Yes	No

Editorial Notes

04/06/2024: Publication reference added.
14/06/2019: Publication reference and total final enrolment number added.