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Nutritional Intervention in Migraine

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ClinicalTrials.gov Identifier: NCT02703129
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Antonio L Teixeira Jr, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Migraine Other: Nutritional intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional Intervention Fin Migraine: A 12-week Open Study
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703129


Locations
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Brazil
Ambulatório Bias Fortes
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Study Director: Adaliene VM Ferreira, PhD Federal University of Minas Gerais
Study Chair: Aline Bárbara P Costa, Ms Federal University of Minas Gerais
Principal Investigator: Antônio L Teixeira, PhD Federal University of Minas Gerais
Study Chair: Laís B Martins, Ms Federal University of Minas Gerais

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Responsible Party: Antonio L Teixeira Jr, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02703129     History of Changes
Other Study ID Numbers: CAAE 0311.0.203.000-11
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by Antonio L Teixeira Jr, Federal University of Minas Gerais:
Migraine
Diet quality
Nutritional intervention
Severity of disease
Depressive symptoms

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases