Back to resultsA Nutritional Intervention for Migraines-2 (WCCR-MIG2)
Primary Purpose
Migraines
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant based diet
an unrestricted diet
Sponsored by
About this trial
This is an interventional supportive care trial for Migraines focused on measuring Migraines, diet, vegan, vegetarian, plant-based
Eligibility 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
Sites / Locations
- Physicians Committee for Responsible Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vegan diet
Supplement group
Arm Description
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
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.
Outcomes
Primary Outcome Measures
Migraines Pain Change in Migraines frequency
Pain as measured by VAS score
Change in Migraines frequency
the reduction in the number of migraine attacks.
Improvement in Mood
mood changes will be measured using the Beck Depression Inventory II (BDI-II).
Improvement in Mood
Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).
Secondary Outcome Measures
Quality of life
Health related quality of life as measured by a questionnaire
Full Information
NCT ID
NCT01699009
First Posted
October 1, 2012
Last Updated
October 19, 2015
Sponsor
Physicians Committee for Responsible Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01699009
Brief Title
A Nutritional Intervention for Migraines-2
Acronym
WCCR-MIG2
Official Title
A Nutritional Intervention for Migraines-2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraines
Keywords
Migraines, diet, vegan, vegetarian, plant-based
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vegan diet
Arm Type
Experimental
Arm Description
The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.
Arm Title
Supplement group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Plant based diet
Intervention Type
Other
Intervention Name(s)
an unrestricted diet
Primary Outcome Measure Information:
Title
Migraines Pain Change in Migraines frequency
Description
Pain as measured by VAS score
Time Frame
Baseline and 4 months
Title
Change in Migraines frequency
Description
the reduction in the number of migraine attacks.
Time Frame
Baseline and 4 months
Title
Improvement in Mood
Description
mood changes will be measured using the Beck Depression Inventory II (BDI-II).
Time Frame
Baseline and 4 months
Title
Improvement in Mood
Description
Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Health related quality of life as measured by a questionnaire
Time Frame
Baseline and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Barnard, MD
Organizational Affiliation
Physicians Committee for Responsible Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physicians Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25339342
Citation
Bunner AE, Agarwal U, Gonzales JF, Valente F, Barnard ND. Nutrition intervention for migraine: a randomized crossover trial. J Headache Pain. 2014 Oct 23;15(1):69. doi: 10.1186/1129-2377-15-69.
Results Reference
derived
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A Nutritional Intervention for Migraines-2
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