School of Life and Health Sciences, University of Roehampton, London, UK.
School of Psychology, University of Roehampton, London, UK.
Prostaglandins Leukot Essent Fatty Acids. 2021 Oct;173:102335. doi: 10.1016/j.plefa.2021.102335. Epub 2021 Aug 25.
Anxiety disorders affect nearly 20% of young adults aged 18-29 years. First-line treatment for anxiety disorders comprises pharmacotherapy and Cognitive Behavioural Therapy, options often criticised for their low efficacy and safety. In contrast, fish-oil-based supplements comprising omega-3 polyunsaturated fatty acids and supporting nutrients are gaining recognition as safe and effective alternatives. Here we present the protocol for a randomised, double-blind, placebo-controlled trial investigating the effects of a high eicosapentaenoic acid multinutrient supplement on validated measures of anxiety and depression in healthy university students experiencing non-clinical levels of anxiety and depression. The primary outcome is improvement in anxiety compared to the placebo group assessed via the Generalised Anxiety Disorder Assessment-7 scale. The participants will be randomised to active treatment comprising a daily dose of 1125 mg eicosapentaenoic acid, 441 mg docosahexaenoic acid, 330 mg magnesium and 7.5 mg vitamin E, or placebo, for 24 weeks, and will complete validated questionnaires and tablet-based tasks sensitive to mood at baseline and end of intervention. Circulating fatty acids and key biomarkers will also be assessed. The students will be genotyped for polymorphisms thought to influence the relationship between long-chain omega-3 polyunsaturated fatty acids and affect. Trial registration; ClinicalTrials.gov, NCT04844034.
焦虑障碍影响近 20%的 18-29 岁年轻成年人。焦虑障碍的一线治疗包括药物治疗和认知行为疗法，但这两种方法的疗效和安全性常受到批评。相比之下，以ω-3 多不饱和脂肪酸和支持性营养素为主要成分的鱼油补充剂，正作为安全有效的替代品得到认可。本研究旨在报告一项随机、双盲、安慰剂对照试验的方案，该试验旨在研究高二十碳五烯酸多营养补充剂对患有非临床水平焦虑和抑郁的健康大学生的焦虑和抑郁的有效性。主要结局是通过广泛性焦虑障碍评估-7 量表评估与安慰剂组相比焦虑的改善情况。参与者将被随机分配到活性治疗组，每天服用 1125mg 二十碳五烯酸、441mg 二十二碳六烯酸、330mg 镁和 7.5mg 维生素 E，或安慰剂，治疗 24 周，并在基线和干预结束时完成敏感评估情绪的验证问卷和基于片剂的任务。还将评估循环脂肪酸和关键生物标志物。将对影响长链 ω-3 多不饱和脂肪酸关系和影响的基因多态性进行学生基因分型。试验注册；ClinicalTrials.gov，NCT04844034。
