Fibromyalgia
Conditions
Keywords
olive polyphenol, Oxidative stress, Inflammation, coagulation, pain, proteomics
Brief summary
To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOlive Polyphenols
Patients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days.
DIETARY_SUPPLEMENTPlacebo
Patients with fibromyalgia of Group 2 will consume a placebo daily during 60 days.
Sponsors
Solvitae Medical, S.L
University of Jaén
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma proteome | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | FIQR (Revised Fibromyalgia Impact Questionnaire) will be used to evaluate the functional capacity in daily living activities |
| 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 | SF-12 (Quality of Life Questionnaire) is used to assess quality of life. |
| 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 | Red blood cells are measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter). |
| 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 | Haemoglobin is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter). |
| 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 | Aldolase is measured using an AU 5800 analyzer (Beckman Coulter). |
| 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 | Total cholesterol is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter). |
| 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 | Cholesterol ratio is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter). |
| 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 | LDL cholesterol is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter). |
| 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 | Cortisol level is determined in serum samples by a fluorescence polarization immunoassay using an AxSYM (Abbott Laboratories, IL, USA). |
| 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 | Fibrinogen is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter). |
| 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 | C-reactive protein (CRP) ie measured using an AU 5800 analyzer (Beckman Coulter). |
Countries
Spain
Outcome results
None listed