Nutritional Intervention in Migraine

March 3, 2016 updated by: Antonio L Teixeira Jr, Federal University of Minas Gerais

Nutritional Intervention Fin Migraine: A 12-week Open Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Ambulatório Bias Fortes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional intervention
Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Study Chair: Aline Bárbara P Costa, Ms, Federal University of Minas Gerais
  • Study Chair: Laís B Martins, Ms, Federal University of Minas Gerais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 0311.0.203.000-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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