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A Nutritional Intervention for Migraines-2 (WCCR-MIG2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01699009
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

Study Description
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Brief Summary:
The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Condition or disease Intervention/treatment Phase
Migraines Other: Plant based diet Other: an unrestricted diet Not Applicable

Detailed Description:

Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. The investigators will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measures are pain as measured by Visual Analog Scale (VAS)and the change in migraines frequency.

Mood change will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Nutritional Intervention for Migraines-2
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vegan diet
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
 Other: Plant based diet
Placebo Comparator: Supplement group
The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.
 Other: an unrestricted diet


Outcome Measures
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Primary Outcome Measures :
  1. Migraines Pain Change in Migraines frequency [ Time Frame: Baseline and 4 months ]
    Pain as measured by VAS score

  2. Change in Migraines frequency [ Time Frame: Baseline and 4 months ]
    the reduction in the number of migraine attacks.

  3. Improvement in Mood [ Time Frame: Baseline and 4 months ]
    mood changes will be measured using the Beck Depression Inventory II (BDI-II).

  4. Improvement in Mood [ Time Frame: Baseline and 4 months ]
    Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline and 4 months ]
    Health related quality of life as measured by a questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders:

At least 5 attacks fulfilling criteria the criteria below:

  • Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  • Headache has at least two of the following characteristics:
  • unilateral location
  • pulsating quality
  • moderate or severe pain intensity
  • aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
  • During headache at least one of the following:
  • nausea and/or vomiting
  • photophobia and phonophobia Not attributed to another disorder
  • Migraines occurring at least twice per month, on average.
  • Age at least 18 years
  • Ability and willingness to participate in all components of the study
  • Willingness to be assigned to either the diet group or supplement group
  • Migraine medications unchanged within last 6 weeks.

Exclusion Criteria:

  • < 18 years of age
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  • Pregnancy
  • Unstable medical or psychiatric illness
  • Likely to be disruptive in group sessions (as determined by research staff)
  • Already following a low-fat, vegan diet
  • Lack of English fluency
  • Inability to maintain current medication regimen
  • Inability or unwillingness to participate in all components of the study
Contacts and Locations
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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): NCT01699009


Locations
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United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
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Principal Investigator: Neal Barnard, MD Physicians Committee for Responsible Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01699009    
Other Study ID Numbers: WCCR-MIG2
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: May 2014
Keywords provided by Physicians Committee for Responsible Medicine:
Migraines, diet, vegan, vegetarian, plant-based
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases