Nutrition for Migraine Prevention
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 7/1/2018 |
| Start Date: | July 2014 |
| End Date: | May 11, 2018 |
Clinical & Metabolic Effects of Altering n-3 & n-6 Fatty Acids in Migraine (RCT)
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.
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.
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.
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.
Inclusion Criteria:
- 18 years of age or older
- Either gender
- Meets 2004 International Classification of Headache Disorders-II* criteria for
Episodic Migraine
- Frequent migraine headaches
- Headache history: > 2 years leading up to study meeting migraine criteria
- Willing to complete daily diary for 26 weeks
- Able to attend 8 dietitian counseling sessions
- Under care of a physician for headaches
- Able to read and communicate in English
Exclusion Criteria:
- Marked depression, anxiety or psychosis.
- History of specific food allergies, such as, but not limited to, dairy or gluten
products
- Pregnancy or anticipated pregnancy
- Active treatment for a major medical illness, such as malignancy, autoimmune, immune
deficiency disorder, etc.
- History of significant head trauma or head/neck surgery within the past 3 years
- History of subarachnoid or intra-cerebral hemorrhage or subdural hematoma
- Allergy to fish or strong aversion to fish consumption.
- History of nervous system infection such as meningitis or encephalitis within the
preceding 5 years
- History of vasculitis, intracranial mass, clotting disorder
- Cognitive dysfunction that would prevent informed consent
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: John D Mann, MD
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