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Fibromyalgia and Olive Oil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245592
Recruitment Status : Active, not recruiting
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Junta de Andalucía
Information provided by (Responsible Party):
Francisco Molina Ortega, University of Jaén

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Dietary Supplement: Extra Virgin Olive Oil Dietary Supplement: Refined Olive Oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Basic Science
Official Title: Fibromyalgia and Oxidative Stress. Influence of the Olive Oil Consumption
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Olive oil

Arm Intervention/treatment
Experimental: Extra Virgin Olive Oil
Women with fibromyalgia will consume Extra Virgin Olive Oil.
Dietary Supplement: Extra Virgin Olive Oil
Before beginning the 3-week dietary trial, participants will conduct a 2-week washout period during which they consumed ROO (50 ml daily for 2 weeks) because they are part of a population that consumes olive oil regularly. After thar, patients of this groups will consume 50 ml/day of organic EVOO for 3 weeks. Biochemical markers and clinical parameters in each participant will be determine before and after the 3-week treatment period.

Experimental: Refined Olive Oil
Women with fibromyalgia will consume Refined Olive Oil.
Dietary Supplement: Refined Olive Oil
Before beginning the 3-week dietary trial, participants will conduct a 2-week washout period during which they consumed ROO (50 ml daily for 2 weeks) because they are part of a population that consumes olive oil regularly. After thar, patients of this groups will consume 50 ml/day of ROO for 3 weeks. Biochemical markers and clinical parameters in each participant will be determine before and after the 3-week treatment period.




Primary Outcome Measures :
  1. Nitric Oxide [ Time Frame: 4 weeks ]
    NO production will be indirectly quantified by measuring nitrate/nitrite and S-nitrose compounds (NOx) using an ozone chemiluminescence-based method.

  2. Cortisol [ Time Frame: 2 weeks ]
    Cortisol level will be determined in serum samples by a fluorescence polarization immunoassay using an AxSYM analyser

  3. IL-6 [ Time Frame: 2 weeks ]
    Interleukin 6 will be analyzed by chemiluminescent immunoassay using the Access Immunoassay Systems (Beckman Coulter)

  4. Lipid peroxidation [ Time Frame: 2 weeks ]
    Quantitation of thiobarbituric acid reactive substances (TBARS) presence

  5. IL-10 [ Time Frame: 2 weeks ]
    Levels of IL-10 will be measured by a chemiluminescent immunoenzymatic assay using an MLX™ luminometer (Dynex Technologies, Chantilly, VA).

  6. C-Reactive Protein [ Time Frame: 2 weeks ]
    CRP will be measured using an AU 5800 analyzer (Beckman Coulter).

  7. Lipid Profile [ Time Frame: 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)

  8. Fibrinogen [ Time Frame: 2 weeks ]
    Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).

  9. Prothrombin activity [ Time Frame: 2 weeks ]
    Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).

  10. Cephaline time [ Time Frame: 2 weeks ]
    Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).

  11. Platelet count [ Time Frame: 2 weeks ]
    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

  12. Platelet distribution width [PDW] [ Time Frame: 2 weeks ]
    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

  13. Mean platelet volume [MPV] [ Time Frame: 2 weeks ]
    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

  14. Red blood cell (RBC) [ Time Frame: 2 weeks ]
    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

  15. Neutrophil count [ Time Frame: 2 weeks ]
    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

  16. Lymphocyte counts [ Time Frame: 2 weeks ]
    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with fibromyalgia will be previously diagnosed with fibromyalgia by a professional rheumatologist and met the American College of Rheumatology (ACR) criteria for fibromyalgia.

Exclusion Criteria:

  • Presence of any other chronic disease (diabetes mellitus, hypertension, rheumatoid arthritis, hepatitis, cancer or ischemic heart disease)
  • Smokers
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245592


Locations
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Spain
Francisco Molina Ortega
Jaén, Spain, 23009
Sponsors and Collaborators
University of Jaén
Junta de Andalucía
Investigators
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Principal Investigator: María Luisa Del Moral, MD University of Jaen
Publications:
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Responsible Party: Francisco Molina Ortega, Associate professor, University of Jaén
ClinicalTrials.gov Identifier: NCT04245592    
Other Study ID Numbers: AGR-6235
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Molina Ortega, University of Jaén:
nutritional intervention
olive oil
nitric oxide
inflammation
cortisol
lipid profile
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases