Department of Neurology, UNC, 2133 Physicians Office Bld, 170 Manning Drive, Chapel Hill, NC 27599-7025, United States.
Department of Physical Medicine and Rehabilitation, UNC School of Medicine, 171 Wing D, C.B.#7200, 170 Manning Drive, Chapel Hill, NC 27599-7200, United States.
Prostaglandins Leukot Essent Fatty Acids. 2018 Jan;128:41-52. doi: 10.1016/j.plefa.2017.11.002. Epub 2017 Nov 16.
Migraine is a prevalent neurological disorder, affecting over 16% of adult women and 7% of adult men in the U.S., causing significant pain, disability, and medical expense, with incomplete benefits from conventional medical management. Migraine, as a chronic pain syndrome, provides a practical model for investigating the impact of dietary modifications in omega-3 (n-3) and omega-6 (n-6) fatty acids. This paper reports the protocol of a trial to assess whether targeted dietary modifications designed to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with or without concurrent reduction in n-6 linoleic acid (LA), will alter nociceptive lipid mediators and mediate decreases in frequency and severity of migraine. This prospective, randomized, controlled trial in 153 male and female adult subjects, ages 18-99, with diagnosed and actively managed episodic migraine tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary omega-3 and omega-6 fatty acids. Participants are masked to diet hypotheses and all assessors are masked to treatment assignment. Following a four-week baseline period, participants with migraine headache frequency of 5-20 per month are randomized to one of three intensive dietary regimens for 16 additional weeks followed by a less intensive observation period. Dietary intervention arms include: 1) increased n-3 EPA+DHA with low n-6 linoleic acid (H3 L6); 2) increased n-3 EPA+DHA with usual US dietary intake of n-6 linoleic acid (H3 H6); and 3) usual US dietary content of n-3 and n-6 fatty acids (L3 H6). During the actual intervention, subjects receive content-specific study oils and foods sufficient for two meals and two snacks per day, as well as dietary counseling. Biochemical and clinical outcome measures are performed at intervals throughout this period. This randomized controlled trial is designed to determine whether targeted alterations in dietary n-3 and n-6 fatty acids can alter nociceptive lipid mediators in a manner that decreases headache pain and enhances quality of life and function in adults with frequent migraines.
NCT02012790.
目的：偏头痛是一种常见的神经系统疾病，影响美国超过 16%的成年女性和 7%的成年男性，导致严重的疼痛、残疾和医疗费用，而常规医学管理的获益不完全。偏头痛作为一种慢性疼痛综合征，为研究饮食中ω-3（n-3）和 ω-6（n-6）脂肪酸的改变对疼痛的影响提供了一个实用的模型。本文报告了一项试验的方案，以评估旨在增加 n-3 二十碳五烯酸（EPA）和二十二碳六烯酸（DHA）、同时减少 n-6 亚油酸（LA）的靶向饮食改变是否会改变伤害性脂质介质，并减轻偏头痛的频率和严重程度。这项针对 153 名年龄在 18-99 岁、诊断为有症状偏头痛并正在接受积极管理的男性和女性成年患者的前瞻性、随机、对照试验，测试了靶向、控制饮食中 ω-3 和 ω-6 脂肪酸的改变的疗效、安全性和生化作用。参与者对饮食假设不知情，所有评估者对治疗分配均不知情。在四周的基线期后，每月偏头痛发作频率为 5-20 次的患者随机分为三组强化饮食方案组，每组 16 周，然后进入非强化观察期。饮食干预组包括：1）增加 n-3 EPA+DHA 并降低 n-6 亚油酸（H3L6）；2）增加 n-3 EPA+DHA 并保持美国常规饮食中 n-6 亚油酸的摄入量（H3H6）；3）美国常规饮食中的 n-3 和 n-6 脂肪酸（L3H6）。在实际干预期间，受试者每天接受两次正餐和两次零食的特定研究油和食物，以满足需求，并接受饮食咨询。在整个试验期间，每隔一段时间进行生化和临床结果测量。这项随机对照试验旨在确定靶向改变饮食中的 n-3 和 n-6 脂肪酸是否能改变伤害性脂质介质，从而减轻头痛疼痛，并提高有频繁偏头痛的成年人的生活质量和功能。
临床试验注册号：NCT02012790。
