采用富含特级初榨橄榄油的地中海饮食预防抑郁症复发。PREDI-DEP 试验：研究方案。
Preventing the recurrence of depression with a Mediterranean diet supplemented with extra-virgin olive oil. The PREDI-DEP trial: study protocol.
机构信息
Nutrition Research Group, Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Paseo Blas Cabrera Felipe Físico s/n, 35016, Las Palmas de Gran Canaria, Spain.
Biomedical Research Center Network on Obesity and Nutrition (CIBERobn) Physiopathology of Obesity and Nutrition, Institute of Health Carlos III, Madrid, Spain.
出版信息
BMC Psychiatry. 2019 Feb 11;19(1):63. doi: 10.1186/s12888-019-2036-4.
BACKGROUND
The role of dietary patterns in the prevention of unipolar depression has been analyzed in several epidemiological studies. The primary aims of this study are to determine the effectiveness of an extra-olive oil-enriched Mediterranean diet in reducing the recurrence of depression and improving the symptoms of this condition.
METHODS
Multicenter, two-arm, parallel-group clinical trial. Arm 1, extra-virgin olive oil Mediterranean diet; Arm 2, control group without nutritional intervention. Dieticians are in charge of the nutritional intervention and regular contact with the participants. Contacts are made through our web platform ( https://predidep.es/participantes/ ) or by phone. Recurrence of depression is assessed by psychiatrists and clinical psychologists through clinical evaluations (semi-structured clinical interviews: Spanish SCID-I). Depressive symptoms are assessed with the Beck Depression Inventory. Information on quality of life, level of physical activity, dietary habits, and blood, urine and stool samples are collected after the subject has agreed to participate in the study and once a year.
DISCUSSION
To the best of our knowledge, the PREDI-DEP trial is the first ongoing randomized clinical trial designed to assess the role of the Mediterranean diet in the prevention of recurrent depression. It could be a cost-effective approach to avoid recurrence and improve the quality of life of these patients.
TRIAL REGISTRATION
The study has been prospectively registered in the U.S. National Library of Medicine ( https://clinicaltrials.gov ) with NCT number: NCT03081065.
背景
多项流行病学研究分析了饮食模式在预防单相抑郁中的作用。本研究的主要目的是确定富含特级初榨橄榄油的地中海饮食在降低抑郁复发率和改善该病症症状方面的有效性。
方法
多中心、双臂、平行组临床试验。第 1 组，特级初榨橄榄油地中海饮食；第 2 组，无营养干预的对照组。营养师负责营养干预和与参与者的定期联系。联系通过我们的网络平台（https://predidep.es/participantes/）或电话进行。通过精神科医生和临床心理学家进行临床评估（西班牙 SCID-I 半结构化临床访谈）来评估抑郁复发情况。抑郁症状使用贝克抑郁量表进行评估。在受试者同意参与研究后和每年一次收集有关生活质量、身体活动水平、饮食习惯以及血液、尿液和粪便样本的信息。
讨论
据我们所知，PREDI-DEP 试验是首个旨在评估地中海饮食在预防复发性抑郁中的作用的正在进行的随机临床试验。它可能是一种经济有效的方法，可以避免这些患者的复发并提高他们的生活质量。
试验注册
该研究已在美国国立医学图书馆（https://clinicaltrials.gov）前瞻性注册，注册号为：NCT03081065。
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