Dietary biomarkers of commonly consumed foods
| ISRCTN | ISRCTN10716294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10716294 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/01/2016
- Registration date
- 15/01/2016
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
University College Dublin (UCD)
UCD Institute of Food and Health
Dublin
D4
Ireland
 ORCID ID |
0000-0002-7711-7499 |
|---|
Study information
| Study design | Single centre randomised cross over trial |
|---|---|
| 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 contact details to request a participant information sheet |
| Scientific title | The identification of dietary biomarkers using a metabolomics based approach |
| Study objectives | Small molecules found in biofluids will reflect dietary intake of specific foods. |
| Ethics approval(s) | University College Dublin (UCD) Human Research Ethics Committee – Sciences, 08/12/2015, ref: LS-15-69-Brennan |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Identification of markers in blood and urine that relate to the consumption of the food. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/12/2015 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 including a 20% dropout |
| Key inclusion criteria | 1. Healthy adults aged between 18 and 60 years old 2. BMI > 18.5 and < 30 kg/m2 |
| Key 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 |
| Date of first enrolment | 04/01/2016 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D4
Ireland
Sponsor information
University/education
Belfield
Dublin
D4
Ireland
"ROR" |
https://ror.org/05m7pjf47 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- ERC
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Biomarkers of apple intake | 20/04/2020 | 10/10/2022 | Yes | No |
Editorial Notes
10/10/2022: Publication reference added.
18/10/2017: Internal review.
18/01/2016: Internal review.
