Condition category
Not Applicable
Date applied
25/10/2013
Date assigned
25/10/2013
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edward Chambers

ORCID ID

Contact details

Du Cane Road
London
W12 0NN
United Kingdom
e.chambers@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14813

Study information

Scientific title

Acronym

Metabolomics for monitoring dietary exposure

Study hypothesis

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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14813

Ethics approval

13/LO/0078; First MREC approval date 28/01/2013

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

Excellent diet, 100% healthy eating targert
Good diet, 75% health eating target
Medium diet, 50% healthy eaying 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(1, 2). Allowing for a dropout rate of 33% we intend to recruit 30 volunteers for the research.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

New Dietary biomarker; Timepoint(s): 4 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2013

Overall trial end date

05/01/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 30

Participant exclusion criteria

1. Weight change of more than 3kg 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

Recruitment start date

01/09/2013

Recruitment end date

05/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Du Cane Road
London
W12 0NN
United Kingdom

Sponsor information

Organisation

Imperial College Healthcare NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.imperial.nhs.uk/

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes