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Prostaglandins Leukot Essent Fatty Acids. 2018 Jan;128:41-52. doi: 10.1016/j.plefa.2017.11.002. Epub 2017 Nov 16.

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.

Author information

1
Department of Neurology, UNC, 2133 Physicians Office Bld, 170 Manning Drive, Chapel Hill, NC 27599-7025, United States. Electronic address: mannj@neurology.unc.edu.
2
Department of Physical Medicine and Rehabilitation, UNC School of Medicine, 171 Wing D, C.B.#7200, 170 Manning Drive, Chapel Hill, NC 27599-7200, United States. Electronic address: faurot@med.unc.edu.
3
UNC Healthcare Department of Nutrition & Food Services - Metabolic & Nutrition Research Core, 102 Mason Farm Rd., CB#7777, Chapel Hill, NC 27599, United States. Electronic address: beth.macintosh@unchealth.unc.edu.
4
Department of Medicine, 4111 Bioinformatics Building, Campus Box 7080, 130 Mason Farm Rd., Chapel Hill, NC 27599-7080, United States. Electronic address: opalsson@med.unc.edu.
5
Department of Biostatistics, Gillings School of Global Public Health, CB # 7420, 3103-A, McGavran-Greenberg Hall, Chapel Hill, NC 27599-7420, United States. Electronic address: suchi@bios.unc.edu.
6
Department of Physical Medicine and Rehabilitation, UNC School of Medicine, 183 Wing D, C.B.#7200, 170 Manning Drive, Chapel Hill, NC 27599-7025, United States. Electronic address: gaylords@med.unc.edu.
7
Department of Physical Medicine and Rehabilitation, UNC School of Medicine, 183 Wing D, C.B.#7200, 170 Manning Drive, Chapel Hill, NC 27599-7025, United States. Electronic address: chanee_lynch@med.unc.edu.
8
North Carolina Department of Agriculture and Consumer Services, 2 West Edenton St., Raleigh, NC 27601, United States. Electronic address: angela.johnston@ncagr.gov.
9
Lipid Mediators, Inflammation, and Pain Unit, Laboratory of Clinical Investigation, National Institute on Aging, NIH, 251 Bayview Blvd., Baltimore, MD 21224, United States. Electronic address: kristen.maiden@nih.gov.
10
UNC Cytokine Analysis Facility, North Carolina Oral Health Institute, 3412 Koury Oral Health Sciences Bldg., CB #7455, Chapel Hill, NC 27599-7455, United States. Electronic address: David_Barrow@unc.edu.
11
Laboratory of Membrane Biochemistry and Biophysics, National Institute on Alcohol Abuse and Alcoholism, NIH, 5625 Fishers Lane, Room 3N-07, Rockville, MD 20892, United States. Electronic address: jhibbeln@mail.nih.gov.
12
Lipid Mediators, Inflammation, and Pain Unit, Laboratory of Clinical Investigation, National Institute on Aging, NIH, 251 Bayview Blvd., Baltimore, MD 21224, United States; Intramural Program of the National Institute on Alcohol Abuse and Alcoholism, NIH, Bethesda, MD 20892, United States; Department of Physical Medicine and Rehabilitation, UNC School of Medicine, 171 Wing D, C.B.#7200, 170 Manning Drive, Chapel Hill, NC 27599, United States. Electronic address: chris.ramsden@nih.gov.

Abstract

Migraine is a prevalent neurological disorder, affecting over 16% of adult women and 7% of adult men in the U.S., causing significant pain, disability, and medical expense, with incomplete benefits from conventional medical management. Migraine, as a chronic pain syndrome, provides a practical model for investigating the impact of dietary modifications in omega-3 (n-3) and omega-6 (n-6) fatty acids. This paper reports the protocol of a trial to assess whether targeted dietary modifications designed to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with or without concurrent reduction in n-6 linoleic acid (LA), will alter nociceptive lipid mediators and mediate decreases in frequency and severity of migraine. This prospective, randomized, controlled trial in 153 male and female adult subjects, ages 18-99, with diagnosed and actively managed episodic migraine tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary omega-3 and omega-6 fatty acids. Participants are masked to diet hypotheses and all assessors are masked to treatment assignment. Following a four-week baseline period, participants with migraine headache frequency of 5-20 per month are randomized to one of three intensive dietary regimens for 16 additional weeks followed by a less intensive observation period. Dietary intervention arms include: 1) increased n-3 EPA+DHA with low n-6 linoleic acid (H3 L6); 2) increased n-3 EPA+DHA with usual US dietary intake of n-6 linoleic acid (H3 H6); and 3) usual US dietary content of n-3 and n-6 fatty acids (L3 H6). During the actual intervention, subjects receive content-specific study oils and foods sufficient for two meals and two snacks per day, as well as dietary counseling. Biochemical and clinical outcome measures are performed at intervals throughout this period. This randomized controlled trial is designed to determine whether targeted alterations in dietary n-3 and n-6 fatty acids can alter nociceptive lipid mediators in a manner that decreases headache pain and enhances quality of life and function in adults with frequent migraines.

TRIAL REGISTRATION:

NCT02012790.

KEYWORDS:

Diet; Headache; Linoleic acid; Lipid mediator; Migraine; Omega-3; Omega-6; Oxylipin, pain; RCT

PMID:
29413360
PMCID:
PMC6269096
DOI:
10.1016/j.plefa.2017.11.002
[Indexed for MEDLINE]
Free PMC Article

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