Journal
CONTEMPORARY CLINICAL TRIALS
Volume 119, Issue -, Pages -Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2022.106851
Keywords
Traumatic brain injury; Post-traumatic headache; Omega-3 fatty acid; Omega-6 fatty acid
Funding
- U.S Army Medical Research and Materiel Command through the Congressionally Directed Medical Research Programs for the Department of Defense through the Henry Jackson Foundation for the Advancement of Military Medicine [W81XwH-15-2-0059]
- National Institute on Aging
- National Institute on Alcohol Abuse and Alcoholism, NIH
- National Center for Advancing Translational Sciences [UL1TR002489]
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This study aims to evaluate the clinical effects of dietary modifications on nociceptive lipid mediators and symptoms in patients with post-traumatic headache (PTH). By conducting a prospective randomized controlled trial, researchers will assess the efficacy and safety of targeted dietary interventions in active-duty service members and military healthcare beneficiaries. The study will measure clinical outcomes and biochemical effects to determine the impact of different dietary regimens on PTH.
Introduction: Post-traumatic headache (PTH) is common after traumatic brain injury (TBI), especially among active-duty service members (SMs), affecting up to 35% of patients with chronic TBI. Persistent PTH is disabling and frequently unresponsive to treatment and is often migrainous. Here, we describe a trial assessing whether dietary modifications to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and reduce n-6 linoleic acid (LA), will alter nociceptive lipid mediators and result in clinical improvements in persistent PTH. Methods: This prospective, randomized, controlled trial tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary n-3 and n-6 fatty acids in 122 adult SMs and military healthcare beneficiaries with diagnosed TBI associated with actively managed persistent frequent (> 8 /month) PTH with migraine. Following a 4-week baseline, participants are randomized to one of two equally intensive dietary regimens for 12 additional weeks: 1) increased n-3 EPA + DHA with low n-6 LA (H3L6); 2) usual US dietary content of n-3 and n-6 fatty acids (Control). During the intervention, participants receive diet arm-specific study oils and foods sufficient for 75% of caloric needs and comprehensive dietary counseling. Participants complete daily headache diaries throughout the intervention. Clinical outcomes, including the Headache Impact Test (HIT -6), headache hours per day, circulating blood fatty acid levels, and bioactive metabolites, are measured pre -randomization and at 6 and 12 weeks. Planned primary analyses include pre-post comparisons of treatment groups on clinical measures using ANCOVA and mixed-effects models. Similar approaches to explore biochemical and exploratory clinical outcomes are planned.
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