A Nutritional Intervention for Migraines-2

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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A Nutritional Intervention for Migraines-2

Conditions
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Migraines

Intervention / Treatment
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* Other: Plant based diet
* Other: an unrestricted diet


Participation Criteria
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Eligibility Criteria
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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: Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) Headache has at least two of the following characteristics: unilateral location pulsating quality moderate or severe pain intensity aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs) During headache at least one of the following: nausea and/or vomiting photophobia and phonophobia Not attributed to another disorder Migraines occurring at least twice per month, on average. Age at least 18 years Ability and willingness to participate in all components of the study Willingness to be assigned to either the diet group or supplement group Migraine medications unchanged within last 6 weeks. Exclusion Criteria: < 18 years of age Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion) Pregnancy Unstable medical or psychiatric illness Likely to be disruptive in group sessions (as determined by research staff) Already following a low-fat, vegan diet Lack of English fluency Inability to maintain current medication regimen Inability or unwillingness to participate in all components of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegan diet<br>The diet group will be asked to follow a low-fat, vegan diet for 16 weeks. | Other: Plant based diet<br> <br> |
| Placebo Comparator: Supplement group<br>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. | Other: an unrestricted diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Health related quality of life as measured by a questionnaire | Baseline and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraines, diet, vegan, vegetarian, plant-based