Effects of Olive Polyphenols in Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

Therapeutic Potential of Olive Polyphenols in Fibromyalgia Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06348537
• Other study ID #: Polyphenol-Fibromyalgia
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2024
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2023
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• Olive Polyphenols
Patients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days.
• Placebo
Patients with fibromyalgia of Group 2 will consume a placebo daily during 60 days.

Locations

Country	Name	City	State
Spain	University of Jaén	Jaén

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Granada	Solvitae Medical, S.L, University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	C-reactive protein (CRP)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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