Nutritional Intervention in Migraine

Migraine Clinical Trial

Official title:

Nutritional Intervention Fin Migraine: A 12-week Open Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703129
• Other study ID #: CAAE 0311.0.203.000-11
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: March 3, 2016
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Brazil	Ambulatório Bias Fortes	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No