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OpenTrials
Completed

NCT Number: NCT02703129

Nutritional Intervention in Migraine

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.

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Key information

Conditions

Migraine Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatório Bias Fortes

Belo Horizonte, Minas Gerais, 30130-100, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional intervention

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Nutritional Intervention Fin Migraine: A 12-week Open Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2016
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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