Nutrition for Chronic Daily Headache

NCT01157208 | Completed DMC

• 1 other identifier: 09-0600
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Daily Headache

Keywords

chronic pain; headache; nutrition; inflammation; complementary medicine

Outcome Measures

Primary Outcomes (1)

• Headache Impact Test

  Headache-related quality-of-life measure

  Pre-intervention and post-intervention

Secondary Outcomes (1)

• Omega-3 and omega-6 fatty acids in RBCs and plasma

  pre-intervention and at 4 and 8 weeks, and at the conclusion of the intervention.

Study Arms (2)

Diet A

EXPERIMENTAL

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

Diet B

EXPERIMENTAL

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

Interventions

Diet A OTHER

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.

Also known as: nutrition

Diet A

Diet B OTHER

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.

Also known as: nutrition

Diet B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Mayday Fund: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7200, United States

Location

Related Publications (4)

• 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 with chronic headache: a secondary analysis of a randomized trial. Pain. 2015 Apr;156(4):587-596. doi: 10.1097/01.j.pain.0000460348.84965.47.

  PMID: 25790451 RESULT

• 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 DJ. Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: a randomized trial. Pain. 2013 Nov;154(11):2441-2451. doi: 10.1016/j.pain.2013.07.028. Epub 2013 Jul 22.

  PMID: 23886520 RESULT

• Ramsden CE, Zamora D, Makriyannis A, Wood JT, Mann JD, Faurot KR, MacIntosh BA, Majchrzak-Hong SF, Gross JR, Courville AB, Davis JM, Hibbeln JR. Diet-induced changes in n-3- and n-6-derived endocannabinoids and reductions in headache pain and psychological distress. J Pain. 2015 Aug;16(8):707-16. doi: 10.1016/j.jpain.2015.04.007. Epub 2015 May 7.

  PMID: 25958314 DERIVED

• Ramsden CE, Mann JD, Faurot KR, Lynch C, Imam ST, MacIntosh BA, Hibbeln JR, Loewke J, Smith S, Coble R, Suchindran C, Gaylord SA. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for chronic daily headache: protocol for a randomized clinical trial. Trials. 2011 Apr 15;12:97. doi: 10.1186/1745-6215-12-97.

  PMID: 21496264 DERIVED

MeSH Terms

Conditions

Headache Disorders; Chronic Pain; Headache; Inflammation

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• John Douglas Mann, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 23, 2017

Record last verified: 2012-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)