Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06348537
Other study ID # Polyphenol-Fibromyalgia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A