Nutrition for Chronic Daily Headache

February 17, 2017 updated by: University of North Carolina, Chapel Hill

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

The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial comparing two potentially analgesic dietary interventions in patients with chronic daily headache (CDH) and 2)To assess the preliminary efficacy of the dietary interventions on headache frequency and severity and 3) to assess the impact of the diet on the percentage of omega-6 highly unsaturated fatty acids (HUFA) in total HUFA in whole blood.

During a 6-week baseline phase, eligible individuals with CDH will complete web-based daily diaries, self-report questionnaires, and nutrient intake assessments. Before randomization to one of the two intervention groups, blood will be collected to measure baseline nutritional biomarkers. Targeted dietary advice will be administered and foods will be provided throughout the 12-week intervention phase. Samples for biomarkers will be collected every 4 weeks during the intervention. Participants will continue recording headache characteristics with a daily headache diary. At the conclusion of the intervention, participants will provide complete follow-up assessments and blood for nutritional biomarker measurement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CDH is characterized by structural and functional immune and nervous system derangements. Specifically, disturbed regulation of the following critically important biochemical processes has been demonstrated: 1) inflammation; 2) neuronal membrane excitability; and 3) monoamine neurotransmitter signaling. Accordingly, major classes of medications used for chronic pain (anti-inflammatories, anticonvulsants, and antidepressants) target these processes.

Foods consist of combinations of nutrient molecules that are incorporated into human tissues, and enter into and regulate highly leveraged human biochemical pathways. By altering the structure and function of the nervous system and immune system, and regulating biochemical processes believed to play causal roles in the development and maintenance of chronic pain, dietary choices may play a critical role in the initiation and/or perpetuation of CDH.

Multifaceted, targeted dietary manipulation, directed towards correcting underlying biochemical derangements, represents a novel therapeutic approach to the management of chronic pain. Improved understanding of the relationships between dietary selections and chronic pain promises to benefit the estimated 10 million Americans with CDH and possibly an even larger population with chronic pain from any origin. For a more detailed description, please refer to the complete rationale and literature review accompanying grant application.

Major research questions for this proposal include:

A. Is it possible to implement a controlled dietary trial comparing two analgesic dietary interventions for subject with CDH? and B. What are the preliminary estimates of impact of targeted analgesic dietary interventions on headache frequency compared with one another and the baseline headache frequency in patients for CDH? C. What is the rate and extent of change in %n6 in HUFA with two targeted interventions? There is also an exploratory portion of the study to gather more information about the potential relationship between nutrient and pain to inform intended future trials. The study is needed to assess the potential utility of a dietary approach for chronic pain, which may have major public health implications.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7200
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • either gender
  • meeting the 2004 International Classification of Headache Disorders (ICHD - II) criteria for the following forms of CDH (15 or more headache days per month and a headache history of more than two years with chronic migraine, transformed episodic migraine into CDH, chronic tension-type headache and new persistent daily headache)
  • under the care of a neurologist
  • willing and able to document headache characteristics and use of medications, as well as complete the assessment instruments
  • able to come in for 3 dietitian-administered dietary counseling sessions over 12 weeks
  • able to speak and understand English

Exclusion Criteria:

  • analgesic rebound headache
  • hemicrania continua
  • drug-induced headache
  • post-traumatic headache
  • significant, symptomatic uncontrolled psychosis
  • undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder
  • pregnancy
  • clotting disorders
  • history of cranial or neck surgery within two years
  • vasculitis
  • chronic subdural hematoma
  • history of meningitis
  • history of subarachnoid or intracerebral hemorrhage
  • history of eating disorder
  • regular use of supplemental omega-3 fatty acids or gamma-linolenic acid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet A
This diet is high in omega-3 fatty acids, low in trans fatty acids, and low in omega-6 fatty acids. Subjects are encouraged to eat fatty fish daily (e.g., salmon), to limit vegetable oil intake, and to eat fruits, vegetables and whole grains. Specifically formulated and other provided foods for this group will include salmon-salad sandwiches, hummus with olive oil, other bean dips and bean dishes, frozen and canned fish, and blueberry-flax muffins.
Other: Diet A
Subjects receive dietary counseling, food for two meals and two snacks daily, and access to a website with recipes, approved food lists, and dining out guides for a 12-week intervention.
Other Names:
  • nutrition
Experimental: Diet B
This diet is low in trans fatty acids and low in omega-6 fatty acids. Subjects are encouraged to to limit vegetable oil intake, to replace meats and eggs with beans and lean fish/shellfish, and to eat fruits, vegetables and whole grains. Specifically formulated and other provided foods for this group will include hummus with olive oil, other bean dips and bean dishes, lean fish and shellfish,and blueberry muffins.
Other: Diet B
Over a 12-week intervention, subjects receive dietary counseling, food for two meals and two snacks daily, and access to a website with recipes, approved food lists, and dining out guides.
Other Names:
  • nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Impact Test
Time Frame: Pre-intervention and post-intervention
Headache-related quality-of-life measure
Pre-intervention and post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omega-3 and omega-6 fatty acids in RBCs and plasma
Time Frame: pre-intervention and at 4 and 8 weeks, and at the conclusion of the intervention.
Highly-unsaturated fatty acids are measured in plasma and red blood cells before the intervention, during the intervention at 4 and 8 weeks, and at the conclusion of the intervention at 12 weeks.
pre-intervention and at 4 and 8 weeks, and at the conclusion of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Mayday Fund

Investigators

  • Principal Investigator: John Douglas Mann, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified data has been shared with NIH.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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