Nutrition for Chronic Daily Headache

Chronic Daily Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157208
• Other study ID #: 09-0600
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: February 17, 2017
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Daily Headache
• Headache
• Headache Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Mayday Fund

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ramsden CE, Faurot KR, Zamora D, Palsson OS, MacIntosh BA, Gaylord S, Taha AY, Rapoport SI, Hibbeln JR, Davis JM, Mann JD. Targeted alterations in dietary n-3 and n-6 fatty acids improve life functioning and reduce psychological distress among patients wi — View Citation

Ramsden CE, Faurot KR, Zamora D, Suchindran CM, Macintosh BA, Gaylord S, Ringel A, Hibbeln JR, Feldstein AE, Mori TA, Barden A, Lynch C, Coble R, Mas E, Palsson O, Barrow DA, Mann JD. Targeted alteration of dietary n-3 and n-6 fatty acids for the treatmen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Impact Test	Headache-related quality-of-life measure	Pre-intervention and post-intervention
Secondary	Omega-3 and omega-6 fatty acids in RBCs and plasma	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.