Nutritional Intervention in Migraine

NCT ID: NCT02703129

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-12-31

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).

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutritional intervention

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

Group Type: EXPERIMENTAL

Nutritional intervention

Intervention Type: OTHER

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

Interventions

Nutritional intervention

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

Intervention Type: OTHER

Eligibility Criteria

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: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Antonio L Teixeira Jr

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adaliene VM Ferreira, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Aline Bárbara P Costa, Ms

Role: STUDY_CHAIR

Federal University of Minas Gerais

Antônio L Teixeira, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Laís B Martins, Ms

Role: STUDY_CHAIR

Federal University of Minas Gerais

Locations

Ambulatório Bias Fortes

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

CAAE 0311.0.203.000-11

Identifier Type: -

Identifier Source: org_study_id