search
Back to results

Nutritional Intervention in Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nutritional intervention
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Diet quality, Nutritional intervention, Severity of disease, Depressive symptoms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

  • Ambulatório Bias Fortes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)
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)

Full Information

First Posted
February 5, 2016
Last Updated
March 3, 2016
Sponsor
Federal University of Minas Gerais
search

1. Study Identification

Unique Protocol Identification Number
NCT02703129
Brief Title
Nutritional Intervention in Migraine
Official Title
Nutritional Intervention Fin Migraine: A 12-week Open Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Diet quality, Nutritional intervention, Severity of disease, Depressive symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional intervention
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Nutritional intervention
Intervention Description
Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis
Primary Outcome Measure Information:
Title
Change in clinical parameters of migraine patients by nutritional intervention in the last month.
Description
Migraine impact/severity in the last month was assessed by HIT-6.
Time Frame
4 weeks
Title
Change in clinical parameters of migraine patients by nutritional intervention in the last three month.
Description
Migraine impact/severity in the last three month was assessed by MIDAS.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in diet quality of migraine patients by nutritional intervention assessed with the Brazilian Healthy Eating Index - Revised (BHEI-R)
Description
Diet quality was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R)
Time Frame
12 weeks
Title
Change in depressive symptoms in migraine patients by nutritional intervention assessed with the Beck Depression Inventory (BDI)
Description
Depressive symptoms were assessed by the Beck Depression Inventory (BDI)
Time Frame
12 weeks

10. Eligibility

Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adaliene VM Ferreira, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aline Bárbara P Costa, Ms
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antônio L Teixeira, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laís B Martins, Ms
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
Facility Information:
Facility Name
Ambulatório Bias Fortes
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Nutritional Intervention in Migraine

We'll reach out to this number within 24 hrs