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The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. The investigators will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measures are pain as measured by Visual Analog Scale (VAS)and the change in migraines frequency.
Mood change will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegan diet | Experimental | The diet group will be asked to follow a low-fat, vegan diet for 16 weeks. |
|
| Supplement group | Placebo Comparator | The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant based diet | Other |
| ||
| an unrestricted diet |
| Measure | Description | Time Frame |
|---|---|---|
| Migraines Pain Change in Migraines frequency | Pain as measured by VAS score | Baseline and 4 months |
| Change in Migraines frequency | the reduction in the number of migraine attacks. | Baseline and 4 months |
| Improvement in Mood | mood changes will be measured using the Beck Depression Inventory II (BDI-II). | Baseline and 4 months |
| Improvement in Mood | Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R). | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Health related quality of life as measured by a questionnaire | Baseline and 4 months |
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Inclusion Criteria:
A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders:
At least 5 attacks fulfilling criteria the criteria below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Barnard, MD | Physicians Committee for Responsible Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25339342 | Derived | Bunner AE, Agarwal U, Gonzales JF, Valente F, Barnard ND. Nutrition intervention for migraine: a randomized crossover trial. J Headache Pain. 2014 Oct 23;15(1):69. doi: 10.1186/1129-2377-15-69. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| D009422 | Nervous System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |