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Completed

NCT Number: NCT06348537

Effects of Olive Polyphenols in Fibromyalgia Patients

To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.

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Key information

Conditions

Fibromyalgia Cardiovascular Diseases Embolism and Thrombosis Inflammation Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Jaén

Jaén, 23071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olive Polyphenols

Dietary Supplement

Patients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days.

Placebo

Dietary Supplement

Patients with fibromyalgia of Group 2 will consume a placebo daily during 60 days.

Primary outcomes

  1. Plasma proteome

    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

    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.

  2. Lipid peroxidation

    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

    Lipid peroxidation is determined by thiobarbituric acid reactive substances (TBARS) method.

Secondary outcomes

  1. Aldolase

    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 is measured using an AU 5800 analyzer (Beckman Coulter).

  2. C-reactive protein (CRP)

    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) ie measured using an AU 5800 analyzer (Beckman Coulter).

  3. Impact of fibromyalgia

    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

    FIQR (Revised Fibromyalgia Impact Questionnaire) will be used to evaluate the functional capacity in daily living activities

  4. 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

    SF-12 (Quality of Life Questionnaire) is used to assess quality of life.

  5. Red blood cells

    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

    Red blood cells are measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).

  6. Haemoglobin

    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 is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).

  7. Fibrinogen

    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 is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).

  8. Total cholesterol

    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 is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).

  9. Cholesterol ratio

    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 is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).

  10. LDL cholesterol

    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 is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).

  11. Cortisol

    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 level is determined in serum samples by a fluorescence polarization immunoassay using an AxSYM (Abbott Laboratories, IL, USA).

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Solvitae Medical, S.L
  • University of Jaén

Registry information

Official study title

Therapeutic Potential of Olive Polyphenols in Fibromyalgia Management

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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