Nutritional Intervention in Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Other: Nutritional intervention

• Registration Number: NCT02703129
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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).

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2016-02-05
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-09
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional intervention	Nutritional intervention	Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ambulatório Bias Fortes; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil