Evidence map›Paper›PMID 29413360›Full record

ArticleProstaglandins, leukotrienes, and essential fatty acids2018

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.

John Douglas Mann, Keturah R Faurot, Beth MacIntosh, Olafur S Palsson, Chirayath M Suchindran, Susan Ann Gaylord, Chanee Lynch, Angela Johnston, Kristen Maiden, David A Barrow and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Prostaglandins, leukotrienes, and essential fatty acids, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02012790 (Clinical & Metabolic Effects of Altering n-3 & n-6 Fatty Acids in Migraine), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02012790 nacompletednot on this map

Clinical & Metabolic Effects of Altering n-3 & n-6 Fatty Acids in Migraine (RCT)

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2014 to 2018Enrolled182ConditionsMigraine DisordersArmsDiet
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 26 citations in OpenAlex.

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  14. Prospects on the Use ofFrontiers in microbiology · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

John Douglas MannDepartment of Neurology, UNC, 2133 Physicians Office Bld, 170 Manning Drive, Chapel Hill, NC 27599-7025, United States. Electronic address: mannj@neurology.unc.edu.
Keturah R FaurotDepartment 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.
Beth MacIntoshUNC 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.
Olafur S PalssonDepartment 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.
Chirayath M SuchindranDepartment 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.
Susan Ann GaylordDepartment 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.
Chanee LynchDepartment 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.
Angela JohnstonNorth Carolina Department of Agriculture and Consumer Services, 2 West Edenton St., Raleigh, NC 27601, United States. Electronic address: angela.johnston@ncagr.gov.
Kristen MaidenLipid 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.
David A BarrowUNC 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.
Joseph R HibbelnLaboratory 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.
Christopher E RamsdenLipid 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.
University of North Carolina Health Care · USNational Institute on Alcohol Abuse and Alcoholism · USNational Institute on Aging · USNorth Carolina Department of Agriculture and Consumer Services · USUniversity of North Carolina at Chapel Hill · US

Funding

The roles of lipid mediators in inflammation, pain, and neuro-degenerationZIAAG000453 · NIA · NATIONAL INSTITUTE ON AGING · PI RAMSDEN, CHRISTOPHER · 2017 to 2025
$35.1M
UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SUSAN M. SMITH · 1999 to 2026
$31.6M
UNC Research Fellowship in Complementary and Alternative MedicineT32AT003378 · NCCIH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Keturah Ruth Faurot, Susan Gaylord · 2007 to 2026
$7.8M
Essential Fatty Acids In Psychiatric DisordersZIAAA000115 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI HIBBELN, JOSEPH · 2009 to 2020
$7.8M
Clinical & metabolic effects of altering n-3 & n-6 fatty acids in migraine (RCT)R01AT007813 · NCCIH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MANN, JOHN DOUGLAS · 2013 to 2017
$3.5M
Intramural NIH HHS Z99 AG999999NCCIH NIH HHS R01 AT007813NCCIH NIH HHS T32 AT003378NIDDK NIH HHS P30 DK056350
6 · The paper itself

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 registrationNCT02012790.

Indexed as

AdolescentAdultAgedAged, 80 and overDocosahexaenoic AcidsFatty Acids, Omega-3FemaleHumansLinoleic AcidMaleMiddle AgedMigraine DisordersRandomized Controlled Trials as TopicDocosahexaenoic AcidsFatty Acids, Omega-3Linoleic AcidDietHeadacheLinoleic acidLipid mediatorMigraineOmega-3Omega-6Oxylipin, painRCT

Identifiers

PMID29413360
PMCPMC6269096
OpenAlexW2770671416

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.