Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/01/2016
Date assigned
15/01/2016
Last edited
18/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 Rrandomised 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

N/A

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

Sponsor information

Organisation

University College Dublin

Sponsor details

Belfield
Dublin
D4
Ireland

Sponsor type

University/education

Website

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

Belgium

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/01/2016: Internal review