Plain English Summary
Background and study aims
Studies looking at the relationship between diet and health require ways of accurately measuring what a person consumes (dietary exposure). It can be very difficult to accurately assess food intake however, as classic methods such as food diaries and food frequency questionnaires are often misleading. It has been suggested that it may be possible to test the body to look for evidence that a particular food has been consumed. By testing bodily fluids such as blood or urine, levels of biomarkers (chemical indicators in the body, such as a specific protein), it may be possible to find a way of accurately measuring whether a person has consumed a particular food. This study aims to identify new biomarkers of food intake with a specific focus on vegetables.
Who can participate?
Healthy, Caucasian adults who are not taking any supplements
What does the study involve?
Participants are randomly allocated to one of four groups, who eat four different foods (carrots, peas, turnips and couscous) at four different study visits, in a random order. At each study visit, participants have a sample of blood and urine taken and are then given a large portion of one of the foods to eat. After six hours, further blood and urine samples are taken, in order to test whether there are any biomarkers that were not present before the food was eaten. Participants are then asked to avoid that specific food for 48 hours, and have repeat blood and urine samples taken at 24 and 48 hours. Following 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 taking part in the study. There are no notable risks of taking part, however participants may experience some pain, discomfort and bruising from the blood tests.
Where is the study run from?
University College Dublin (UK)
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 (Ireland)
2. Science Foundation Ireland (Ireland)
3. University College Dublin (Ireland)
Who is the main contact?
Professor Lorraine Brennan
Trial website
Contact information
Type
Scientific
Primary contact
Prof Lorraine Brennan
ORCID ID
http://orcid.org/0000-0002-7711-7499
Contact details
University College Dublin
Belfield
Dublin
Dublin 4
Ireland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Discovery of novel biomarkers of carrots and legumes intake
Acronym
Study hypothesis
Following food intake biomarkers specific to the food will appear in urine and blood.
Ethics approval
University College Dublin Human Research Ethics Committee – Sciences, 05/11/2015, ref: LS-15-63-Brennan
Study design
Randomised cross-over study
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 below to request a patient information sheet.
Condition
Biomarkers of food intake
Intervention
Participants are randomly allocated to one of four groups, who will each consume one of the following foods in random order.
Food A: Carrots
Food B: Peas
Food C: Turnips
Food D: Couscous
Large portions of each food will be consumed on separate study visits (4 study day visits) and postprandial samples will be taken up to 6 hours following consumption. A fasting sample will also be taken 24 and 48 hours post consumption of each food. The foods of interest will be avoided by participants during this time period.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Presence of biomarkers of food intake in urine and blood are measured 6 hours post-consumption of each food and at 24 and 48 hours post-consumption.
Secondary outcome measures
N/A
Overall trial start date
04/01/2016
Overall trial end date
01/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Caucasian adults
2. Non smokers
3. BMI >18.5 and <30 kg/m2
4. Free of chronic or infectious disease
5. Not taking any medication (oral contraceptive pill is allowed)
6. Not taking supplements
7. Not pregnant, lactating
8. No antibiotics in the 6 previous months
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
12
Total final enrolment
16
Participant exclusion criteria
BMI greater than 30 kg/m2
Recruitment start date
04/01/2016
Recruitment end date
01/12/2016
Locations
Countries of recruitment
Ireland
Trial participating centre
University College Dublin
Institute of Food and Health
Belfield
Dublin
Dublin 4
Ireland
Sponsor information
Organisation
University College Dublin
Sponsor details
Belfield
Dublin
D4
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Joint Programming Initiative
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Science Foundation Ireland
Alternative name(s)
SFI
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Ireland
Funder name
University College Dublin
Alternative name(s)
UCD
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Ireland
Results and Publications
Publication and dissemination plan
Planned publication of study results in a peer reviewed journal.
Intention to publish date
31/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 pea intake biomarker results in https://www.ncbi.nlm.nih.gov/pubmed/30518059 (added 28/06/2019)