Discovery of novel biomarkers of food intake
| ISRCTN | ISRCTN70680593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70680593 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/12/2015
- Registration date
- 23/12/2015
- Last edited
- 28/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
University College Dublin
Belfield
Dublin
Dublin 4
Ireland
 ORCID ID |
0000-0002-7711-7499 |
|---|
Study information
| Study design | Randomised cross-over study |
|---|---|
| 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 below to request a patient information sheet. |
| Scientific title | Discovery of novel biomarkers of carrots and legumes intake |
| Study objectives | Following food intake biomarkers specific to the food will appear in urine and blood. |
| Ethics approval(s) | University College Dublin Human Research Ethics Committee – Sciences, 05/11/2015, ref: LS-15-63-Brennan |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/01/2016 |
| Completion date | 01/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 |
| Total final enrolment | 16 |
| Key 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 |
| Key exclusion criteria | BMI greater than 30 kg/m2 |
| Date of first enrolment | 04/01/2016 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Belfield
Dublin
Dublin 4
Ireland
Sponsor information
University/education
Belfield
Dublin
D4
Ireland
| Website | http://www.ucd.ie/foodandhealth/ |
|---|---|
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Not defined
No information available
Government organisation / National government
- Alternative name(s)
- SFI
- Location
- Ireland
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UCD
- Location
- Ireland
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication of study results in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pea intake biomarker results | 04/12/2018 | 28/06/2019 | Yes | No |
Editorial Notes
28/06/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number has been added.
