search
Back to results

A Nutritional Intervention for Migraines

Primary Purpose

Migraines

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vegan Diet
mixture of omega3 and vitamins
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Migraines focused on measuring Migraines, Diet, Vegetarian, Diet, Fat-Restricted, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders18

    • 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
  2. Migraines occurring at least twice per month, on average.
  3. Age at least 18 years
  4. Ability and willingness to participate in all components of the study
  5. Willingness to be assigned to either the diet group or supplement group
  6. Migraine medications unchanged within last 6 weeks.

Exclusion Criteria:

  1. < 18 years of age
  2. 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
  3. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
  4. Pregnancy
  5. Unstable medical or psychiatric illness
  6. Likely to be disruptive in group sessions (as determined by research staff)
  7. Already following a low-fat, vegan diet
  8. Lack of English fluency
  9. Inability to maintain current medication regimen
  10. 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

Placebo Comparator

Experimental

Arm Label

Dietary Supplement

Vegan Diet

Arm Description

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.

Secondary Outcome Measures

Quality of life
Health related quality of life as measured by a questionnaire

Full Information

First Posted
February 27, 2012
Last Updated
May 13, 2013
Sponsor
Physicians Committee for Responsible Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01547494
Brief Title
A Nutritional Intervention for Migraines
Official Title
A Nutritional Intervention for Migraines
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (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.
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. We 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraines
Keywords
Migraines, Diet, Vegetarian, Diet, Fat-Restricted, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement
Arm Type
Placebo Comparator
Arm Title
Vegan Diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Vegan Diet
Intervention Description
Vegan diet, which is devoid of animal products and minimal in fat
Intervention Type
Dietary Supplement
Intervention Name(s)
mixture of omega3 and vitamins
Intervention Description
mixture of omega3 and vitamins
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
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
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 Disorders18 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
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

Learn more about this trial

A Nutritional Intervention for Migraines

We'll reach out to this number within 24 hrs