Nutrition for Migraine Prevention

NCT02012790 | Completed DMC

• 3 other identifiers: 13-3284UL1TR0000831R01AT007813-01A1
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine Disorders

Keywords

Migraine disorders

Outcome Measures

Primary Outcomes (2)

• Primary metabolic outcome: 17-hydroxy docosahexaenoic acid (DHA)

  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.

  Change in 17-hydroxy DHA at 16 weeks

• Primary clinical outcome: Headache-specific Quality of Life (HIT-6)

  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"

  Change in HIT-6 at 16 weeks

Secondary Outcomes (4)

• Headache hours per day (headache frequency) are measured by a daily Headache Diary

  Trajectory of change: -4 to 0 weeks (pre-intervention), 0-16 weeks (intervention), and 16-22 weeks (post-intervention)

• Patient-Reported Outcomes Measurement Information System-29 Profile

  Pre-post and trajectory of change measured at randomization and at 4,10, and 16 weeks after randomization

• 17-hydroxy DHA trajectory

  Trajectory of change in 17-hydroxy DHA 0-16 weeks and 16-22 weeks

• HIT-6

  Trajectory of change pre-intervention, 0-16 weeks, and 16-22 weeks

Other Outcomes (3)

• Migraine Disability Assessment Score (MIDAS)

  Change in MIDAS from randomization to 16 weeks after randomization

• Medication use for treatment of headache.

  trajectory of change over 16 weeks

• Unusual symptoms

  Daily for 4 weeks before randomization, and 22 weeks after randomization

Study Arms (3)

Diet A

EXPERIMENTAL

Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks.

Other: Diet

Diet B

EXPERIMENTAL

Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks.

Other: Diet

Diet C

ACTIVE COMPARATOR

Whole food diet modifies dietary fatty acids. Foods provided for 16 weeks; study oils provided for 22 weeks.

Other: Diet

Interventions

Diet OTHER

The dietary intervention provides dietary counseling, whole foods (enough for 2 meals and 2 snacks per day) including study oils

Diet A; Diet B; Diet C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UNC Program on Integrative Medicine

Chapel Hill, North Carolina, 27599-7200, United States

Location

Related Publications (4)

• Faurot KR, Park J, Miller V, Honvoh G, Domeniciello A, Mann JD, Gaylord SA, Lynch CE, Palsson O, Ramsden CE, MacIntosh BA, Horowitz M, Zamora D. Dietary fatty acids improve perceived sleep quality, stress, and health in migraine: a secondary analysis of a randomized controlled trial. Front Pain Res (Lausanne). 2023 Oct 25;4:1231054. doi: 10.3389/fpain.2023.1231054. eCollection 2023.

  PMID: 37954068 DERIVED

• Ramsden CE, Zamora D, Faurot KR, MacIntosh B, Horowitz M, Keyes GS, Yuan ZX, Miller V, Lynch C, Honvoh G, Park J, Levy R, Domenichiello AF, Johnston A, Majchrzak-Hong S, Hibbeln JR, Barrow DA, Loewke J, Davis JM, Mannes A, Palsson OS, Suchindran CM, Gaylord SA, Mann JD. Dietary alteration of n-3 and n-6 fatty acids for headache reduction in adults with migraine: randomized controlled trial. BMJ. 2021 Jun 30;374:n1448. doi: 10.1136/bmj.n1448.

  PMID: 34526307 DERIVED

• Miller VE, Faurot KR, Palssson OS, MacIntosh BA, Suchindran C, Honvoh G, Gaylord S, Ramsden CE, Mann JD. Comparing prospective headache diary and retrospective four-week headache questionnaire over 20 weeks: Secondary data analysis from a randomized controlled trial. Cephalalgia. 2020 Nov;40(13):1523-1531. doi: 10.1177/0333102420949180. Epub 2020 Aug 16.

  PMID: 32799667 DERIVED

• Mann JD, Faurot KR, MacIntosh B, Palsson OS, Suchindran CM, Gaylord SA, Lynch C, Johnston A, Maiden K, Barrow DA, Hibbeln JR, Ramsden CE. A sixteen-week three-armed, randomized, controlled trial investigating clinical and biochemical effects of targeted alterations in dietary linoleic acid and n-3 EPA+DHA in adults with episodic migraine: Study protocol. Prostaglandins Leukot Essent Fatty Acids. 2018 Jan;128:41-52. doi: 10.1016/j.plefa.2017.11.002. Epub 2017 Nov 16.

  PMID: 29413360 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Diet

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• John D Mann, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: December 16, 2013
• Study Start: July 1, 2014
• Primary Completion: March 29, 2018
• Study Completion: May 11, 2018
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

US (1)