Plain English Summary
Background and study aims
Assessment of dietary intake is key to understand the links between diet and health. Here, researchers are going to study molecules in urine and blood samples to that them an insight into what people have eaten. These new molecules are called dietary biomarkers. This study will help to identify new molecules that can act as biomarkers of commonly consumed foods. These can then be used in the assessment of diet, identification of diet-related diseases and used how to explain how a dietary intervention (programme) will work , thereby adding to scientific knowledge.
Who can participate?
Healthy adults between 18-60 with a body mass index (BMI) between 18.5 and 30 kg/m2.
What does the study involve?
Each participant is asked to eat one of each of the following foods at a time, in a random order: broccoli, red bell peppers, oranges, apples, madeira sponge cake, spaghetti, white bread, wholemeal bread and cheddar cheese. They are asked for urine and blood samples for up to 4 hours after eating each food. They are also asked for a fasting blood sample and urine sample one day after eating the foods. The samples are then analysed for dietary biomarkers.
What are the possible benefits and risks of participating?
There are no known benefits or risks to taking part in this study.
Where is the study run from?
University College Dublin (Ireland)
When is the study starting and how long is it expected to run for?
December 2015 to December 2017
Who is funding the study?
European Research Council (Belgium)
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 (UCD)
UCD Institute of Food and Health
Dublin
D4
Ireland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The identification of dietary biomarkers using a metabolomics based approach
Acronym
Study hypothesis
Small molecules found in biofluids will reflect dietary intake of specific foods.
Ethics approval
University College Dublin (UCD) Human Research Ethics Committee – Sciences, 08/12/2015, ref: LS-15-69-Brennan
Study design
Single centre randomised 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 contact details to request a participant information sheet
Condition
Dietary biomarkers
Intervention
Randomised study where subjects will consume one of the following in random order on one occasion only and samples will be collected following consumption (up to 4 h post consumption):
Broccoli, red bell peppers, oranges, apples, madeira sponge cake, spaghetti, white bread, wholemeal bread and cheddar cheese.
One day after consumption of the foods a fasting blood and urine sample will also be collected.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Identification of markers in blood and urine that relate to the consumption of the food.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/12/2015
Overall trial end date
01/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy adults aged between 18 and 60 years old
2. BMI > 18.5 and < 30 kg/m2
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
24 including a 20% dropout
Participant exclusion criteria
1. Smokers
2. Diagnosed health condition (chronic or infectious disease)
3. Taking medication (oral contraceptive pill is allowed)
4. Pregnant, lactating
5. Allergies/intolerances to any of specified test foods
Recruitment start date
04/01/2016
Recruitment end date
01/01/2017
Locations
Countries of recruitment
Ireland
Trial participating centre
University College Dublin (UCD)
Dublin 4
Dublin
D4
Ireland
Funders
Funder type
Government
Funder name
European Research Council
Alternative name(s)
ERC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
01/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary