Effects of Olive Polyphenols in Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Dietary Supplement: Olive Polyphenols; Dietary Supplement: Placebo

• Registration Number: NCT06348537
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study Start: 2021-01-20
• Primary Completion: 2021-04-01
• Study Completion: 2023-09-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Olive Polyphenols	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.
Group 2	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Plasma proteome	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.
Lipid peroxidation	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 Outcome Measures

Name	Time	Method
Red blood cells	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).
Aldolase	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).
LDL cholesterol	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).
Fibrinogen	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).
Total cholesterol	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).
Cholesterol ratio	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).
C-reactive protein (CRP)	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).
Impact of fibromyalgia	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
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	SF-12 (Quality of Life Questionnaire) is used to assess quality of life.
Haemoglobin	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).
Cortisol	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).

Trial Locations

Locations (1)

University of Jaén; 🇪🇸 Jaén, Spain