Dietary biomarker discovery using metabolomics

ISRCTN	ISRCTN43087333
DOI	https://doi.org/10.1186/ISRCTN43087333
Secondary identifying numbers	14813

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

Du Cane Road
London
W12 0NN
United Kingdom

Phone	+44 (0)20 7589 5111
Email	e.chambers@imperial.ac.uk

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a 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	New dietary biomarker; timepoint(s): 4 weeks
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2013
Completion date	05/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target number of participants	UK Sample Size: 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

England
United Kingdom

Study participating centre

Du Cane Road

London
W12 0NN
United Kingdom

Sponsor information

Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre

International Centre for Circulatory Health
59 North Wharf Road
London
W2 1LA
England
United Kingdom

Website	http://www.imperial.nhs.uk/
"ROR"	https://ror.org/056ffv270

Funders

Funder type

Research council

MRC CTU (UK); Grant Codes: MR/J010308/1

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

29/09/2022: Publication reference and total final enrolment added.
17/01/2017: Publication reference added.