Condition category
Nervous System Diseases
Date applied
04/02/2009
Date assigned
13/03/2009
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A migraine is a severe headache felt as a throbbing pain at the front or side of the head. The cause of migraine is still not completely understood and treatment is complicated by the differing symptoms experienced. The most common treatments are drugs, either over the counter or those prescribed by a GP or specialist. Some people find that avoiding certain foods and drinks can reduce the number and/or severity of their migraines. The aim of this study is to find out whether a simple blood test is able to identify foods to which people with migraine may be sensitive, and to test whether eliminating these foods from the diet reduces their migraine symptoms.

Who can participate?
Patients aged 18 to 65 who have migraines

What does the study involve?
Participants undergo a pin prick blood test to detect food intolerances. Participants with a positive test result (that is, they are found to have at least one food intolerance) are randomly allocated to one of two groups, either the True Diet (treatment) or Sham Diet (control) group. Both groups are given a diet sheet and are asked to eliminate all foods on their diet sheet for a period of 12 weeks. The True Diet group are sent a diet sheet with the results of their food intolerance test, while the Sham Diet group are sent a diet sheet of equal difficulty but the foods listed are not the true results of their test. Both groups are asked to follow the diet for 12 weeks, completing a daily diary and questionnaires at various time points. At the end of 12 weeks they are asked to reintroduce in a stepwise fashion the foods which they have been asked to eliminate. They are asked to reintroduce one food at a time on a weekly basis and continue with the food if no migraine occurs. This occurs over a 4-week period with all eliminated foods (if no migraine has occurred) being introduced in the final week. At the end of the study all participants are told which diet group they were allocated to and those in the Sham Diet group are provided with their true diet sheet.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
York Trials Unit, Department of Health Sciences, University of York (UK)

When is the study starting and how long is it expected to run for?
March 2008 to February 2009

Who is funding the study?
University of York (UK)

Who is the main contact?
Prof David Torgerson

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Torgerson

ORCID ID

Contact details

York Trials Unit
Department of Health Sciences
Area 4
Seebohm Rowntree Building
University of York
Heslington
York
YO10 5DD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of food elimination diet based on the enzyme linked immuno-sorbent assay (ELISA) test for food sensitivity for the prevention of migraine

Acronym

Study hypothesis

To assess whether the use of a simple linked immuno-sorbent assay (ELISA) test followed by dietary elimination will reduce migraine symptoms.

Ethics approval

Research Governance Committee in the Department of Health Sciences at the University of York, 28/04/2008

Study design

Pragmatic double-blind two-arm randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Migraine

Intervention

Participants with a positive ELISA test (that is they have at least one food intolerance) will be randomised to one of two groups, either the True Diet (treatment) or Sham Diet (control) group. The True Diet group will be sent the results of their test while the Sham Diet group will be sent a diet sheet of equal difficulty but the foods listed will not be the true results of their test. Both dietary change groups are asked to follow the diet for a period of 12 weeks. At the end of 12 weeks they are asked to reintroduce, in a stepwise fashion the foods which they have been asked to eliminate. They will be asked to reintroduce one food at a time on a weekly basis and continue with the food if no migraine occurs. This will occur over a 4-week period with all eliminated foods (if no migraine has occurred) being introduced in the final week. All participants will be given the result of their ELISA test at the end of the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in number of headache days over the 12 week period. The Migraine Disability Assessment (MIDAS) Questionnaire will be used for this outcome - "On how many days in the last four weeks did you have a headache? (If a headache lasted more than 1 day, count each day)" at baseline, 4 weeks, 12 weeks and 16 weeks.

Secondary outcome measures

Measured at baseline, 4 weeks, 12 weeks and 16 weeks:
1. Total MIDAS score
2. Six-item Total Headache Impact Test (HIT-6) score
3. Number of migraine days

Overall trial start date

25/03/2008

Overall trial end date

14/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Between the ages of 18 - 65 years, either sex
2. Have had two or more migraine attacks (or four or more headache days) in the previous 4 week period
3. Have no other significant co-existing pathology, e.g. have had or currently suffering from an eating disorder (anorexia nervosa/bulimia nervosa)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

25/03/2008

Recruitment end date

14/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York - York Trials Unit
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK) - York Trials Unit

Sponsor details

Department of Health Sciences
Area 4
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

University/education

Funder name

University of York

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21835022

Publication citations

  1. Results

    Mitchell N, Hewitt CE, Jayakody S, Islam M, Adamson J, Watt I, Torgerson DJ, Randomised controlled trial of food elimination diet based on IgG antibodies for the prevention of migraine like headaches., Nutr J, 2011, 10, 85, doi: 10.1186/1475-2891-10-85.

Additional files

Editorial Notes

29/01/2016: Publication reference added.