A Nutritional Intervention for Migraines-2

Migraines Clinical Trial

— WCCR-MIG2  

Official title:

A Nutritional Intervention for Migraines-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699009
• Other study ID #: WCCR-MIG2
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: October 19, 2015
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Migraine Disorders
• Migraines

Intervention

Other:
• Plant based diet

• an unrestricted diet

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraines Pain Change in Migraines frequency	Pain as measured by VAS score	Baseline and 4 months	No
Primary	Change in Migraines frequency	the reduction in the number of migraine attacks.	Baseline and 4 months	No
Primary	Improvement in Mood	mood changes will be measured using the Beck Depression Inventory II (BDI-II).	Baseline and 4 months	No
Primary	Improvement in Mood	Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).	Baseline and 4 months	No
Secondary	Quality of life	Health related quality of life as measured by a questionnaire	Baseline and 4 months	No