Nutrition for Migraine Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02012790
First received: November 5, 2013
Last updated: August 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Migraine Disorders
Other: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical & Metabolic Effects of Altering n-3 & n-6 Fatty Acids in Migraine (RCT)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Primary metabolic outcome: 17-hydroxy docosahexaenoic acid (DHA) [ Time Frame: Change in 17-hydroxy DHA at 16 weeks ] [ Designated as safety issue: No ]
    17-hydroxy DHA is the pathway marker and precursor to two families of potent bioactive mediators with analgesic properties (D series resolvins and protectins), which will be measured at baseline and after 16 weeks of diet exposure.

  • Primary clinical outcome: Headache-specific Quality of Life (HIT-6) [ Time Frame: Change in HIT-6 at 16 weeks ] [ Designated as safety issue: No ]
    The HIT-6 is a validated questionnaire designed "to measure the impact that headaches have on the ability to function on the job, at school, at home, and in social situations"


Secondary Outcome Measures:
  • Headache hours per day (headache frequency) are measured by a daily Headache Diary [ Time Frame: Trajectory of change: -4 to 0 weeks (pre-intervention), 0-16 weeks (intervention), and 16-22 weeks (post-intervention) ] [ Designated as safety issue: No ]
    Subjects will be instructed to maintain a daily record of their headaches using a headache diary. Subjects will be asked to record the frequency, intensity, and duration of their headaches by rating their headaches hourly as "none", "mild", "moderate" and "severe". Hours of sleep will also be indicated. In our clinical trial of a migraine headache treatment, subjects were willing and able to complete daily diaries with minimal loss of data. Diaries will be completed on a secure website via a computer or smart-phone interface. Numbers of hours of any headache will be calculated along with numbers of hours of moderate to severe headache for use in longitudinal models.

  • Patient-Reported Outcomes Measurement Information System-29 Profile [ Time Frame: Pre-post and trajectory of change measured at randomization and at 4,10, and 16 weeks after randomization ] [ Designated as safety issue: No ]
    This battery of short instruments covers the following domains associated with chronic pain: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social role, pain interference, and pain intensity

  • 17-hydroxy DHA trajectory [ Time Frame: Trajectory of change in 17-hydroxy DHA 0-16 weeks and 16-22 weeks ] [ Designated as safety issue: No ]
    17-hydroxy DHA is the pathway marker and precursor to two families of potent bioactive mediators with analgesic properties (D series resolvins and protectins), which will be measured at baseline, after 4, 10, and 16 weeks of diet exposure, and at the end of the observation period (22 weeks).

  • HIT-6 [ Time Frame: Trajectory of change pre-intervention, 0-16 weeks, and 16-22 weeks ] [ Designated as safety issue: No ]
    The HIT-6 is a validated questionnaire designed "to measure the impact that headaches have on the ability to function on the job, at school, at home, and in social situations" measured at baseline, randomization, and after 4,10, and 16 weeks on the diet and at the end of the observation period (22 weeks)


Other Outcome Measures:
  • Migraine Disability Assessment Score (MIDAS) [ Time Frame: Change in MIDAS from randomization to 16 weeks after randomization ] [ Designated as safety issue: No ]
    Disability, defined as the consequences of illness on ability to work and function, will be measured using the headache disability assessment score (MIDAS). Derived from the Headache Impact Test, MIDAS is a 7-item questionnaire that assesses the number of days during the previous three months that respondents missed work or school, experienced decreased productivity at work or home, or missed social engagements because of headaches. Test-retest reliability is acceptable, with Spearman's correlation coefficient ranging from 0.67 to 0.73. Cronbach's alpha is 0.83

  • Medication use for treatment of headache. [ Time Frame: trajectory of change over 16 weeks ] [ Designated as safety issue: No ]
    Subjects enter number of doses of medications used for treatment of headaches into their daily diaries.

  • Unusual symptoms [ Time Frame: Daily for 4 weeks before randomization, and 22 weeks after randomization ] [ Designated as safety issue: Yes ]
    Subjects will record unusual symptoms in a comment field in their daily diaries.


Estimated Enrollment: 153
Study Start Date: July 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet A
Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks.
Other: Diet
The dietary intervention provides dietary counseling, whole foods (enough for 2 meals and 2 snacks per day) including study oils
Experimental: Diet B
Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks.
Other: Diet
The dietary intervention provides dietary counseling, whole foods (enough for 2 meals and 2 snacks per day) including study oils
Active Comparator: Diet C
Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks.
Other: Diet
The dietary intervention provides dietary counseling, whole foods (enough for 2 meals and 2 snacks per day) including study oils

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02012790

Contacts
Contact: Angela Johnston, BS 919-966-8586 angela_johnston@med.unc.edu
Contact: Kim R Faurot, PA, PhD 919-966-8586 faurot@med.unc.edu

Locations
United States, North Carolina
UNC Program on Integrative Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599-7200
Principal Investigator: John D Mann, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: John D Mann, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02012790     History of Changes
Other Study ID Numbers: 13-3284, UL1TR000083, 1R01AT007813-01A1
Study First Received: November 5, 2013
Last Updated: August 11, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Migraine disorders

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

ClinicalTrials.gov processed this record on October 20, 2014