Dietary biomarker discovery using metabolomics
| ISRCTN | ISRCTN43087333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43087333 |
| Protocol serial number | 14813 |
| Sponsor | Imperial College Healthcare NHS Trust (UK) |
| Funder | MRC CTU (UK); Grant Codes: MR/J010308/1 |
- Submission date
- 25/10/2013
- Registration date
- 25/10/2013
- Last edited
- 29/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Edward Chambers
Scientific
Scientific
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)20 7589 5111 |
|---|---|
| e.chambers@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Dietary biomarker discovery using metabolomics |
| Study objectives | Current strategies for reducing chronic disease burden in the UK and elsewhere emphasize the importance of changing dietary habits. Developing population level dietary interventions and monitoring their effectiveness require robust tools for assessing dietary exposure in large scale studies. The aim of the present study is to identify novel chemicals in blood and urine that are associated with a healthy diet. Volunteers will be given diets differing in amounts of specific test foods deemed to have high public health importance (oily fish, wholegrain foods, fruits and vegetables). Whilst provided with these diets urine and blood samples will be collected to determine new biomarkers for these different food sources. |
| Ethics approval(s) | 13/LO/0078; First MREC approval date 28/01/2013 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Excellent diet, 100% healthy eating target Good diet, 75% health eating target Medium diet, 50% healthy eating target Poor diet, 25% of health eating target Follow Up Length: 1 month Study Entry: Single Randomisation only A formal power calculation is not possible as this will be the first study of its type. However, recent studies have demonstrated significant changes in metabolomics profiles in cohorts of 20 volunteers. Allowing for a dropout rate of 33% we intend to recruit 30 volunteers for the research. |
| Intervention type | Other |
| Primary outcome measure(s) |
New dietary biomarker; timepoint(s): 4 weeks |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 05/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Aged between 21 and 65 years 2. Male or female with a body mass index (weight in kg over height in metres squared) between 20-35 |
| Key exclusion criteria | 1. Weight change of more than 3 kg in the preceding 2 months 2. Current smokers 3. Substance abuse 4. Excess alcohol intake 5. Pregnancy 6. Diabetes 7. Cardiovascular disease 8. Cancer 9. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 10. Kidney disease 11. Liver disease 12. Pancreatitis 13. Use of medications including: antiinflammatory drugs or steroids, androgens, phenytoin, erythromycin or thyroid hormones |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 05/01/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Du Cane Road
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2017 | Yes | No | |
| Results article | 22/09/2022 | 29/09/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/09/2022: Publication reference and total final enrolment added.
17/01/2017: Publication reference added.
