Expired Study
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Chapel Hill, North Carolina 27599


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.


Study summary:

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.


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


NCT ID:

NCT01157208


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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