Fibromyalgia and Oxidative Stress. Influence of the Olive Oil Consumption
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Fibrinogen
研究概览
简要总结
We have recently reported a prothrombotic state in patients with fibromyalgia that may increase the risk of thrombosis-related cardiovascular disease in these patients. Several studies have shown the cardioprotective, antithrombotic and antiinflammatory properties of olive oil. The objective of the study is to investigate the effect of consumption of two types of olive oils with different antioxidant content on thrombosis-related parameters, nitric oxide, inflammation, lipid profile and cortisol as well as on health-related parameters in women with fibromyalgia.
详细描述
Aim:
The goal of the present study is to investigate the effects of two olive oils with different antioxidant content on cardiovascular risk factors (blood-coagulation parameters, platelet indices, red blood cell count, inflammatory markers, lipid profile, nitric oxide and cortisol) in patients diagnosed with fibromyalgia. The investigators will determine thrombosis-related parameters (fibrinogen levels, prothrombin time, prothrombin activity, cephaline time, platelet count, platelet distribution width [PDW], mean platelet volume [MPV], plateletcrit, red blood cell [RBC] count, neutrophil-to-lymphocyte ratio [NLR], and platelet-to-lymphocyte ratio [PLR]), inflammatory markers (interleukin 6 [IL-6], IL-10, C-reactive protein [CRP], erythrocyte sedimentation rate (ESR)), nitric oxide levels, lipid profile, and cortisol levels.
Participants:
This study will be carry out in accordance with the provisions of the Declaration of Helsinki of the World Medical Association.
The research group will contact a Spanish association of patients with fibromyalgia, AFIXA (Association of Fibromyalgia of Jaén, Spain) to find patients to participate in the study. The researchers will convene patients in the laboratory of the Faculty of Health Sciences of the University of Jaén (Spain) to obtain several data of interest (age, BMI, other chronic diseases, pregnancy, lactation and medication). Based on these data, the investigators will select the fibromyalgia group. In a second visit to the laboratory, all patients will sign an informed consent form, the blood samples will be taken and the they will complete several questionnaires (Fibromyalgia Impact Questionnaire, Visual Analogic Scale, Short Form 12 Health Survey).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients were blinded to the kind of olive oil consumed using unlabeled bottles.
A coding number in the blood samples of the patients were used to blind the Investigators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with fibromyalgia will be previously diagnosed with fibromyalgia by a professional rheumatologist and met the American College of Rheumatology (ACR) criteria for fibromyalgia.
排除标准
- •Presence of any other chronic disease (diabetes mellitus, hypertension, rheumatoid arthritis, hepatitis, cancer or ischemic heart disease)
- •Dyslipidemia
- •Pregnancy
- •Lactation
- •Grade II obesity (BMI ≥ 35 kg/m2)
- •Under anticoagulant, corticosteroid, estrogen, analgesic or anti-inflammatory treatment (or they have stopped using them at least 2 months before the start of our study).).
- •Patients who consume alcohol regularly
结局指标
主要结局
Fibrinogen
时间窗: 2 weeks
Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).
Platelet count
时间窗: 2 weeks
Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).
Mean platelet volume [MPV]
时间窗: 2 weeks
Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).
IL-6
时间窗: 2 weeks
Interleukin 6 will be analyzed by chemiluminescent immunoassay using the Access Immunoassay Systems (Beckman Coulter)
Lipid Profile
时间窗: 2 weeks
Serum lipid profile (total cholesterol, high-density lipoprotein \[HDL\]-cholesterol, triglycerides, apolipoprotein A1, and apolipoprotein B) will be measured by a spectrophotometric procedure using an OLYMPUS AU 5400 analyzer (Beckman Coulter). Low-density lipoprotein (LDL)-cholesterol levels will be estimated indirectly with the Friedewald equation. The level of homocysteine will be determined by a fluorescence polarization immunoassay using an AxSYM analyzer (Abbott Laboratories)
Red blood cell (RBC)
时间窗: 2 weeks
Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).
Neutrophil count
时间窗: 2 weeks
Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).
Lymphocyte counts
时间窗: 2 weeks
Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).
Lipid peroxidation
时间窗: 2 weeks
Quantitation of thiobarbituric acid reactive substances (TBARS) presence
Prothrombin activity
时间窗: 2 weeks
Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).
Cephaline time
时间窗: 2 weeks
Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).
Nitric Oxide
时间窗: 4 weeks
NO production will be indirectly quantified by measuring nitrate/nitrite and S-nitrose compounds (NOx) using an ozone chemiluminescence-based method.
Cortisol
时间窗: 2 weeks
Cortisol level will be determined in serum samples by a fluorescence polarization immunoassay using an AxSYM analyser
IL-10
时间窗: 2 weeks
Levels of IL-10 will be measured by a chemiluminescent immunoenzymatic assay using an MLX™ luminometer (Dynex Technologies, Chantilly, VA).
C-Reactive Protein
时间窗: 2 weeks
CRP will be measured using an AU 5800 analyzer (Beckman Coulter).
Platelet distribution width [PDW]
时间窗: 2 weeks
Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).
次要结局
未报告次要终点
研究者
Francisco Molina Ortega
Associate professor
University of Jaén