Nutrition for Chronic Daily Headache
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|ClinicalTrials.gov Identifier: NCT01157208|
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Daily Headache||Other: Diet A Other: Diet B||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Dietary Interventions for Chronic Daily Headache (CDH): A Feasibility Study,|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
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 Name: 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 Name: nutrition
- Headache Impact Test [ Time Frame: Pre-intervention and post-intervention ]Headache-related quality-of-life measure
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157208
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7200|
|Principal Investigator:||John Douglas Mann, MD||University of North Carolina, Chapel Hill|