Therapeutic Potential of Olive Polyphenols in Fibromyalgia Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasma proteome
研究概览
简要总结
To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.
详细描述
This work has studied the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM, analyzing the complete blood count, the biochemical, lipid and coagulation profiles as well as the inflammatory and oxidative statuses in blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients to be included in the study must be female over 18 years of age. The patients had to be previously diagnosed with FM according to the criteria of the American College of Rheumatology.
排除标准
- •Other chronic diseases: diabetes mellitus, hypertension, cardiovascular disorders, cancer...
- •Patients with grade II obesity (body mass index ≥ 35 kg/m2).
- •Active smokers.
- •Pregnancy.
- •Regular treatment with acetylsalicylic acid, estrogen, corticosteroids, antioxidants or lipid-lowering drugs.
- •Participation in another research study.
结局指标
主要结局
Plasma proteome
时间窗: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 3 months
Proteomic analyses will be performed by liquid nano-chromatography coupled to label-free tandem mass spectrometry (label-free nLC-MS/MS). This technique allows the relative quantification of the abundance of each protein in each sample, making it possible to assess those with differential expression in the different study groups.
Lipid peroxidation
时间窗: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Lipid peroxidation is determined by thiobarbituric acid reactive substances (TBARS) method.
次要结局
- Red blood cells(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- Aldolase(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- LDL cholesterol(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- Fibrinogen(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- Total cholesterol(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- Cholesterol ratio(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- C-reactive protein (CRP)(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- Impact of fibromyalgia(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 20 minutes)
- Quality of Life(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 20 minutes)
- Haemoglobin(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
- Cortisol(It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month)
研究者
ALMA RUS MARTÍNEZ
PhD
Universidad de Granada