Clinical trial NCT02703129: Nutritional Intervention in Migraine
Official title: Nutritional Intervention Fin Migraine: A 12-week Open Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Diet quality
Nutritional intervention
Severity of disease
Depressive symptoms
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 52
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in clinical parameters of migraine patients by nutritional intervention in the last month.
timeFrame: 4 weeks
measure: Change in clinical parameters of migraine patients by nutritional intervention in the last three month.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in diet quality of migraine patients by nutritional intervention assessed with the Brazilian Healthy Eating Index - Revised (BHEI-R)
timeFrame: 12 weeks
measure: Change in depressive symptoms in migraine patients by nutritional intervention assessed with the Beck Depression Inventory (BDI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Ambulatório Bias Fortes
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Adaliene VM Ferreira, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Aline Bárbara P Costa, Ms
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Antônio L Teixeira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Laís B Martins, Ms
role: STUDY_CHAIR
References: