Silva Ana Rita, Bernardo Alexandra, de Mesquita Maria Fernanda, Vaz Patto José, Moreira Pedro, Silva Maria Leonor, Padrão Patrícia
Faculdade de Ciências da Nutrição e Alimentação, Universidade do Porto, Rua Dr. Roberto Frias, 4200-465, Porto, Portugal.
Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Instituto Universitário Egas Moniz, Almada, Portugal.
Trials. 2021 Mar 9;22(1):198. doi: 10.1186/s13063-021-05146-3.
This study aims to analyze the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of fibromyalgia (FM) patients.
A sample of 100 female patients diagnosed with FM, followed up at Portuguese Institute of Rheumatology (IPR) in Lisbon, is being randomly allocated in two groups. Patients in the intervention group are adopting an anti-inflammatory diet, characterized by the exemption of the intake of foods containing gluten, dairy, sugar, and ultra-processed foods, during 3 months. During the first month, a low fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) diet is implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months. Patients in the control group are adopting a diet based on general recommendations for healthy eating. The outcomes are pain, fatigue, quality of sleep, quality of life, gastrointestinal symptoms, and inflammation. Before and after the 3 months intervention, and also 1 month after beginning the intervention, the following questionnaires are applied: Revised Fibromyalgia Impact Questionnaire, visual analog pain scale, Brief Pain Inventory,visual analog scale from a list of common gastrointestinal and extraintestinal symptoms in FM, Short Form 36, Fatigue Severity Survey, and Pittsburg Sleep Quality Index. Ultra-sensitive serum C-reactive protein, eritrocyte sedimentation rate, and interleukin-8 are determined. Age, physical activity, anthropometric parameters, and body composition are being collected. Student's t test will assess the association between the disease evaluation parameters, the inflammatory markers, and the dietary interventions.
The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention.
www.ClinicalTrials.gov NCT04007705 . Registered on July 5, 2019.
本研究旨在分析一种具有潜在抗炎作用的营养干预措施对纤维肌痛（FM）患者疾病评估参数、炎症标志物和生活质量的影响。
选取100名在里斯本葡萄牙风湿病研究所（IPR）接受随访的确诊为FM的女性患者作为样本，随机分为两组。干预组患者在3个月内采用抗炎饮食，其特点是不摄入含麸质、乳制品、糖和超加工食品的食物。在第一个月，实施低可发酵寡糖、双糖、单糖和多元醇（FODMAPs）饮食，同时搭配抗炎饮食，随后在连续2个月的时间里重新引入所有水果和蔬菜。对照组患者采用基于健康饮食一般建议的饮食。观察指标包括疼痛、疲劳、睡眠质量、生活质量、胃肠道症状和炎症。在3个月干预前后以及干预开始后1个月，应用以下问卷：修订版纤维肌痛影响问卷、视觉模拟疼痛量表、简明疼痛评估量表、FM常见胃肠道和肠外症状列表的视觉模拟量表、36项简短健康调查、疲劳严重程度调查和匹兹堡睡眠质量指数。测定超敏血清C反应蛋白、红细胞沉降率和白细胞介素-8。收集年龄、身体活动、人体测量参数和身体成分数据。采用学生t检验评估疾病评估参数、炎症标志物与饮食干预之间的关联。
本研究结果有望确定患者营养的改变是否有助于缓解症状，从而优化医疗干预。
www.ClinicalTrials.gov NCT04007705。于2019年7月5日注册。
