Clinical trial NCT06348537: Effects of Olive Polyphenols in Fibromyalgia Patients
Official title: Therapeutic Potential of Olive Polyphenols in Fibromyalgia Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: olive polyphenol
Oxidative stress
Inflammation
coagulation
pain
proteomics
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Solvitae Medical, S.L
name: University of Jaén
First posted: 2024-04-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma proteome
timeFrame: 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
measure: Lipid peroxidation
timeFrame: 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
Secondary outcomes:
measure: Aldolase
timeFrame: 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: C-reactive protein (CRP)
timeFrame: 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: Impact of fibromyalgia
timeFrame: 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
measure: Quality of Life
timeFrame: 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
measure: Red blood cells
timeFrame: 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: Haemoglobin
timeFrame: 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: Fibrinogen
timeFrame: 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: Total cholesterol
timeFrame: 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: Cholesterol ratio
timeFrame: 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: LDL cholesterol
timeFrame: 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: Cortisol
timeFrame: 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
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: University of Jaén
Study officials:
affiliation: University of Jaén
name: Mª Luisa del Moral, MD
role: PRINCIPAL_INVESTIGATOR
References: