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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01699009
First received: October 1, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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 Intervention
Migraines
Other: Plant based diet
Other: an unrestricted diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Nutritional Intervention for Migraines-2

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • Migraines Pain Change in Migraines frequency [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Pain as measured by VAS score

  • Change in Migraines frequency [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    the reduction in the number of migraine attacks.

  • Improvement in Mood [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    mood changes will be measured using the Beck Depression Inventory II (BDI-II).

  • Improvement in Mood [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Health related quality of life as measured by a questionnaire


Enrollment: 24
Study Start Date: October 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699009

Locations
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
Principal Investigator: Neal Barnard, MD Physicians Committee for Responsible Medicine
  More Information

No publications provided

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01699009     History of Changes
Other Study ID Numbers: WCCR-MIG2
Study First Received: October 1, 2012
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Physicians Committee for Responsible Medicine:
Migraines, diet, vegan, vegetarian, plant-based

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

ClinicalTrials.gov processed this record on September 18, 2014