Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
09/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to find a new way of measuring what people eat and drink on a regular basis. What people eat and drink and how it is prepared can affect our weight and our chances of developing certain diseases, such as heart disease, diabetes and many cancers. The aim is to understand what substances end up in the urine and blood after eating different foods and drinks, and whether these chemicals can be used to identify what someone has been eating, how much, how long ago, how it was cooked and the quality. The study’s findings should enable better monitoring of the nation’s diet and whether people are following healthy eating guidelines.

Who can participate?
Healthy people between the ages of 18-80 who are normal weight or overweight and live in the North East of England

What does the study involve?
Over a two or three week period, participants follow set meal plans and collect urine samples at regular times. The meal plans are made up of regular food and organised into a normal meal pattern. Participants visit the research facility at the beginning of each week to collect their food and drink. They make a second visit to the research facility at the end of each week to give a blood sample, return the urine samples they collected, and discuss how the study went for them.

What are the possible benefits and risks of participating?
There are no direct benefits to those taking part, but participating may help the researchers to develop a more accurate way of measuring what food and drink people consume on a regular basis and how healthy the British diet is. Participants may experience minor discomfort when giving blood and mild bleeding or bruising afterwards. If a participant has never eaten some of the test foods, there is a very small chance of an allergic reaction. However, all the foods are commonly eaten by most people and participants are asked to declare any known food allergy before joining the study.

Where is the study run from?
The study is a collaboration between Newcastle University, Aberystwyth University and Imperial College London, but all participants come to the Newcastle University research facilities to take part.

When is the study starting and how long is it expected to run for?
March 2014 to December 2014

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
1. Dr Naomi Willis (naomi.willis@ncl.ac.uk)
2. Prof. John Mathers (john.mathers@ncl.ac.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Naomi Willis

ORCID ID

Contact details

Human Nutrition Research Centre
Institute of Cellular Medicine
Newcastle University
Campus for Ageing and Vitality
Newcastle Upon Tyne
NE4 5PL
United Kingdom
-
naomi.willis@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16037

Study information

Scientific title

Identification of metabolomic biomarkers to assess dietary exposure in free-living adults

Acronym

MAIN

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.

Ethics approval

First MREC approval date 14/01/2014, ref: 14/EM/0040

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

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Intervention

Participants will be given short-term diets lasting three days and will take part for a maximum of three consecutive weeks. These diets will contain 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. Participants will follow the diets in different orders and the order they follow will be decided by a random number generator (random.org). Whilst provided with these diets, urine and blood samples will be collected to identify new biomarkers for these different foods/food groups and 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. No follow-up will take place after the study has been completed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Clearly distinguishable metabolomic profiles for chosen foods/food groups, measured using mass spectrometry from samples collected on Days 1 - 5 of each study week

Secondary outcome measures

1. Distinguishable metabolomic profiles for chosen foods when using minimally invasive urine sampling
2. Distinguishable metabolomic profiles for different food formulations
Both measured using mass spectrometry from samples collected on Days 1 - 5 of each study week

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 18.5-29.9 kg/m2)

Participant type

Healthy volunteer

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
Institute of Cellular Medicine Newcastle University Campus for Ageing and Vitality
Newcastle Upon Tyne
NE4 5PL
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/J010308/1

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

Planned publication of methodology and findings in relevant peer reviewed journals by December 2017.

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes