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
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
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
-
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.