Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/12/2015
Date assigned
23/12/2015
Last edited
23/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

Presence of biomarkers of food intake in urine and blood are measured 6 hours post-consumption of eat 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

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

Participant exclusion criteria

BMI greater than 30

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

http://www.ucd.ie/foodandhealth/

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

private sector organisation

Funding Body Subtype

foundation

Location

Ireland

Funder name

University College Dublin

Alternative name(s)

UCD

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes