To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Patients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days.
Patients with fibromyalgia of Group 2 will consume a placebo daily during 60 days.
University of Jaén
Jaén, Spain
Plasma proteome
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.
Time frame: 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
Lipid peroxidation
Lipid peroxidation is determined by thiobarbituric acid reactive substances (TBARS) method.
Time frame: 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
Aldolase is measured using an AU 5800 analyzer (Beckman Coulter).
Time frame: 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)
C-reactive protein (CRP) ie measured using an AU 5800 analyzer (Beckman Coulter).
Time frame: 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
FIQR (Revised Fibromyalgia Impact Questionnaire) will be used to evaluate the functional capacity in daily living activities
Time frame: 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
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SF-12 (Quality of Life Questionnaire) is used to assess quality of life.
Time frame: 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
Red blood cells
Red blood cells are measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).
Time frame: 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
Haemoglobin is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).
Time frame: 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
Fibrinogen is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).
Time frame: 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
Total cholesterol is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).
Time frame: 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
Cholesterol ratio is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).
Time frame: 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
LDL cholesterol is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).
Time frame: 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
Cortisol level is determined in serum samples by a fluorescence polarization immunoassay using an AxSYM (Abbott Laboratories, IL, USA).
Time frame: 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