Nutrition for Migraine Prevention
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Migraine is a widespread, debilitating, chronic pain disorder and a major public health
      challenge. Most conventional, pharmaceutical treatments fail to give satisfactory long-term
      relief and their repeated use can have important side effects. This project involves
      implementation of substantial dietary changes in adults with migraine. Our goal is to test
      the hypothesis that a causal relationship exists between migraine symptoms and the amount and
      proportions of foods consumed containing defined amounts of polyunsaturated fatty acids.

      Significant findings supporting the hypothesis will lead to a major shift in both prevention
      and management of migraine and other chronic pain disorders. Emphasis is on low-cost, health
      improvement strategies utilizing specific dietary modifications for pain management, based on
      solid clinical research evidence.
    

Detailed description: 
      Episodic migraine is a debilitating chronic pain condition afflicting 12% of American adults.
      Current conventional treatments rely on medications that provide limited or transient relief,
      target symptoms rather than the underlying causes of pain, and are associated with
      significant side effects and costs. It is therefore essential to investigate
      non-pharmacologic approaches to conventional headache treatments. Certain fatty acids and
      their bioactive metabolites regulate multiple pain-related biochemical pathways. Controlled
      clinical trials investigating pain modulation in response to dietary changes while exploring
      relevant mechanisms of action in humans are lacking.

      In a recent feasibility study in patients with chronic daily headache (CDH), we found that
      targeted fatty acid modifications altered circulating endovanilloids, while reducing headache
      frequency and improving quality of life. These findings support our proposed model in which
      diet-induced alterations in endovanilloids modulate transient receptor potential cation
      channel subfamily V member 1 (TRPV1) activity in vivo, leading to important implications for
      migraine and chronic pain in general.

      The goal of this research is to assess whether dietary PUFA modifications can result in
      predicted changes in circulating endovanilloids and improvement in headache-related clinical
      outcomes. The proposed 3-arm, 26-week,randomized, controlled, single-blind trial, with 51
      subjects in each group, includes a 4-week baseline of usual care, followed by randomization
      to one of three 22-week dietary interventions plus usual care. Each of the three arms
      involves specific modifications of dietary fatty acid intakes through a whole foods diet.
      Participants in the dietary interventions receive food sufficient for 2 meals and 2 snacks
      daily along with extensive dietary counseling.

      Specific aims are:

        1. To assess the efficacy of the dietary interventions in inducing the predicted changes in
           circulating fatty acid endovanilloid derivatives;

        2. To compare the clinical effects in migraine specific outcomes of two 16-week analgesic
           dietary interventions with each other and a control diet;

        3. To test, in an exploratory manner, our model of the proposed causal chain linking
           changes in fatty acids, their endovanilloid derivatives, and headache clinical
           endpoints.

      This proposal utilizes an innovative design and hypotheses to address current research
      funding priorities, by examining clinical efficacy and underlying mechanisms of a promising
      dietary manipulation with the distinct potential for high impact in terms of ameliorating a
      chronic, disabling pain disorder.
    

Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): The dietary intervention provides dietary counseling, whole foods (enough for 2 meals and 2 snacks per day) including study oils
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine disorders