Evidence map›Paper›PMID 21496264›Full record

Trial reportTrials2011

Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for chronic daily headache: protocol for a randomized clinical trial.

Christopher E Ramsden, J Douglas Mann, Keturah R Faurot, Chanee Lynch, Syed Taha Imam, Beth A MacIntosh, Joseph R Hibbeln, James Loewke, Sunyata Smith, Rebecca Coble and 2 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01157208 (Dietary Interventions for Chronic Daily Headache), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% 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.

NCT01157208 nacompletednot on this map

Dietary Interventions for Chronic Daily Headache (CDH): A Feasibility Study,

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2009 to 2011Enrolled67ConditionsChronic Daily HeadacheArmsDiet A, Diet B
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
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  16. RNA-Seq investigations of human post-mortem trigeminal ganglia.Cephalalgia : an international journal of headache · 2018
    Article
  17. Article
  18. A Clinical Approach to Addressing Diet with Migraine Patients.Current neurology and neuroscience reports · 2017
    Review
  19. Article
  20. Article
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 2 institutions in 1 country.

Christopher E RamsdenSection on Nutritional Neurosciences, Laboratory of Membrane Biochemistry and Biophysics, NIAAA, NIH, Bethesda, MD, USA. chris.ramsden@nih.gov
J Douglas Mann
Keturah R Faurot
Chanee Lynch
Syed Taha Imam
Beth A MacIntosh
Joseph R Hibbeln
James Loewke
Sunyata Smith
Rebecca Coble
Chirayath Suchindran
Susan A Gaylord
University of North Carolina at Chapel Hill · USNational Institutes of Health · US

Funding

UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD: BPCAUL1RR025747 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$44.6M
UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
Carolina Population CenterR24HD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MORGAN, SAMUEL PHILIP · 2005 to 2014
$10.0M
Nutritional Effects On Essential Fatty Acid CompositionZIAAA000235 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI HIBBELN, JOSEPH · 2009 to 2020
$8.2M
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
NCCIH NIH HHS T32-AT003378NCRR NIH HHS UL1RR025747NICHD NIH HHS R24 HD050924NIDDK NIH HHS DK056350
6 · The paper itself

Abstract

backgroundTargeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH). High intakes of the omega-6 (n-6) polyunsaturated fatty acids (PUFAs), linoleic acid (LA) and arachidonic acid (AA) may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A) both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B) the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity.

methodsAdults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks.

resultsSubject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence.

trial registrationClinicalTrials.gov (NCT01157208).

Indexed as

Chronic DiseaseClinical ProtocolsDietary SupplementsFatty Acids, Omega-3Fatty Acids, Omega-6FemaleHeadacheHumansMalePatient ComplianceFatty Acids, Omega-3Fatty Acids, Omega-6

Identifiers

PMID21496264
PMCPMC3096579
OpenAlexW2152077362

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.