Migraine Nervous System Diseases Migraine
Conditions
Interventions
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 Tr
Sponsors
University of York (UK) - York Trials Unit
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed