Nutrition for Chronic Daily Headache

This study has been completed.
Sponsor:
Collaborator:
Mayday Fund
Information provided by (Responsible Party):
Douglas Mann, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01157208
First received: May 28, 2010
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial comparing two potentially analgesic dietary interventions (a low omega-6 plus high omega-3 diet and a low omega-6 alone diet) 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.


Condition Intervention Phase
Chronic Daily Headache
Other: Low omega-6 plus high omega-3 diet
Other: Low omega-6 diet
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dietary Interventions for Chronic Daily Headache (CDH): A Feasibility Study,

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Headache Impact Test [ Time Frame: Pre-intervention and post-intervention ] [ Designated as safety issue: No ]
    Headache-related quality-of-life measure


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 67
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low omega-6 plus high omega-3 Diet
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: Low omega-6 plus high omega-3 diet
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 Name: nutrition
Experimental: Low omega-6 Diet
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: Low omega-6 diet
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 Name: nutrition

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157208

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7200
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Mayday Fund
Investigators
Principal Investigator: John Douglas Mann, MD University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Mann, MD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01157208     History of Changes
Other Study ID Numbers: 09-0600
Study First Received: May 28, 2010
Last Updated: November 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
chronic pain
headache
nutrition
inflammation
complementary medicine

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014