Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
03/04/2014
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 Naomi Willis

ORCID ID

Contact details

Human Nutrition Research Centre
School of Clinical Medical Sciences
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
naomi.willis@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16037

Study information

Scientific title

Acronym

Metabolomics to characterize diet (The MAIN Study)

Study hypothesis

Current strategies for reducing chronic disease burden in the UK emphasize the importance of changing dietary habits. Determining the effectiveness of healthy eating initiatives requires robust tools to assess dietary intake at the population level. The aim of this study is to identify novel chemicals (biomarkers) in blood and urine which are associated with healthy and unhealthy diets. Volunteers will be given short-term diets containing specific test foods deemed to have high public health importance (oily fish, wholegrain foods, fruits and vegetables), as well as high fat and sugary foods which are associated with obesity. Whilst provided with these diets, urine and blood samples will be collected to a) identify new biomarkers for these different foods / food groups and b) to establish the optimum urine sampling procedure which has minimal intrusion on normal daily life but is suitable for assessment of dietary exposure in large scale epidemiological studies.

Ethics approval

14/EM/0040; First MREC approval date 14/01/2014

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

Topic: Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes)

Intervention

Everyday foods, To assess whether a standardised evening meal on the pre-study day is necessary for metabolomic biomarker discovery. Subjects will follow a 3-day menu plan incorporating foods commonly consumed by the UK population, e.g. oily fish, whole grains, fruit, vegetables, as well as high fat and sugary foods.; Food formulation, To understand the effect of food component presentation / formulation on metabolomic biomarker sensitivity; Timing and dosage, To understand the effect of timing of food consumption and dosage on metabolomic biomarker signal strength

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clearly distinguishable metabolomic profiles for chosen foods / food groups; Timepoint(s): After recruitment is completed

Secondary outcome measures

1. Distinguishable metabolomic profiles for chosen foods when using minimally invasive urine sampling; Timepoint(s): After recruitment is completed
2. Distinguishable metabolomic profiles for different food formulations; Timepoint(s): After recruitment is completed

Overall trial start date

31/03/2014

Overall trial end date

19/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-80
2. Male or female
3. Normal weight or overweight (Body mass index 18.5-29.9kg/m2)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; 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 (Type 1 and Type 2)
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. Food allergy
14. Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal imbalance, including but not exclusive to: antiinflammatory drugs (NSAIDs), steroids or other immunosuppressive medication, androgens, phenytoin, erythromycin or thyroid hormones.

Subjects with the above conditions / taking the above medications would have an altered pattern of hormones and inflammatory molecules because of their disease process which may lead to misleading results.

Recruitment start date

31/03/2014

Recruitment end date

19/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Human Nutrition Research Centre
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK); Grant Codes: MR/010308/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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