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| Name | Class |
|---|---|
| Solvitae Medical, S.L | UNKNOWN |
| University of Jaén | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1: consisting of 20 patients diagnosed with FM, who received a daily dose of 3 capsules (2 in the morning and 1 in the evening) of Mygrium® during 60 days. |
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| Group 2 | Placebo Comparator | Group 2: 20 patients diagnosed with FM, who received a daily dose of 3 capsules (2 in the morning and 1 in the evening) of a placebo (maltodextrins) during 60 days. This intervention group served as a control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olive Polyphenols | Dietary Supplement | Patients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Aldolase | Aldolase is measured using an AU 5800 analyzer (Beckman Coulter). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mª Luisa del Moral, MD | University of Jaén | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Jaén | Jaén | 23071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39337423 | Derived | de la Cruz Cazorla S, Blanco S, Rus A, Molina-Ortega FJ, Ocana E, Hernandez R, Visioli F, Moral MLD. Nutraceutical Supplementation as a Potential Non-Drug Treatment for Fibromyalgia: Effects on Lipid Profile, Oxidative Status, and Quality of Life. Int J Mol Sci. 2024 Sep 14;25(18):9935. doi: 10.3390/ijms25189935. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D007249 | Inflammation |
| D013927 | Thrombosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Placebo | Dietary Supplement | Patients with fibromyalgia of Group 2 will consume a placebo daily during 60 days. |
|
C-reactive protein (CRP) ie measured using an AU 5800 analyzer (Beckman Coulter).
| 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 | 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 | SF-12 (Quality of Life Questionnaire) is used to assess 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 |
| Red blood cells | Red blood cells are measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter). | 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). | 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). | 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). | 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). | 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). | 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). | 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 |
| D009422 |
| Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |