A Nutritional Intervention for Migraines-2 (WCCR-MIG2)
|ClinicalTrials.gov Identifier: NCT01699009|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : October 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Migraines||Other: Plant based diet Other: an unrestricted diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|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|
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|
- Migraines Pain Change in Migraines frequency [ Time Frame: Baseline and 4 months ]Pain as measured by VAS score
- Change in Migraines frequency [ Time Frame: Baseline and 4 months ]the reduction in the number of migraine attacks.
- Improvement in Mood [ Time Frame: Baseline and 4 months ]mood changes will be measured using the Beck Depression Inventory II (BDI-II).
- 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).
- Quality of life [ Time Frame: Baseline and 4 months ]Health related quality of life as measured by a questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699009
|United States, District of Columbia|
|Physicians Committee for Responsible Medicine|
|Washington, District of Columbia, United States, 20016|
|Principal Investigator:||Neal Barnard, MD||Physicians Committee for Responsible Medicine|