Nutritional Intervention in Migraine

Study Overview
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Brief Summary
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Migraine is a common medical condition. Several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. The aim of the current study was to evaluate whether nutritional intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of patients with migraine.

Detailed Description
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Women with the diagnosis of migraine according to the International Headache Society (IHS-2) criteria received individualized diet meal plan and nutritional orientation for 12 weeks according to their nutritional diagnosis. Patients were evaluated three times with an interval of 30 days between each visit. Clinical, anthropometric measurements (weight, height, waist circumference and body composition assessed by bioelectrical impedance analysis) and food evaluations were performed. Nutritional orientations were strengthened in each visit. The diet prescription did not change during intervention period. The diet quality of the patients was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R) version. Migraine severity was assessed with the Headache Impact Test (HIT) and the Migraine Disability Assessment Scale (MIDAS). Depressive symptoms were also evaluated with the Beck Depression Inventory (BDI).

Official Title
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Nutritional Intervention Fin Migraine: A 12-week Open Study

Conditions
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Migraine

Intervention / Treatment
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* Other: Nutritional intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women; Older than 18 years; Migraine diagnosis; Agree to sign the informed consent. Exclusion Criteria: Patients with headaches not characterized as migraine; Pregnant or lactating women.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention<br>Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis | Other: Nutritional intervention<br>* Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical parameters of migraine patients by nutritional intervention in the last month. | Migraine impact/severity in the last month was assessed by HIT-6. | 4 weeks | 
| Change in clinical parameters of migraine patients by nutritional intervention in the last three month. | Migraine impact/severity in the last three month was assessed by MIDAS. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet quality of migraine patients by nutritional intervention assessed with the Brazilian Healthy Eating Index - Revised (BHEI-R) | Diet quality was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R) | 12 weeks | 
| Change in depressive symptoms in migraine patients by nutritional intervention assessed with the Beck Depression Inventory (BDI) | Depressive symptoms were assessed by the Beck Depression Inventory (BDI) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Diet quality, Nutritional intervention, Severity of disease, Depressive symptoms