Effects of Olive Polyphenols in Fibromyalgia Patients

NCT06348537 | Completed

• 1 other identifier: Polyphenol-Fibromyalgia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

olive polyphenol; Oxidative stress; Inflammation; coagulation; pain; proteomics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Dietary Supplement: Olive Polyphenols

Group 2

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Olive Polyphenols DIETARY_SUPPLEMENT

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

Group 1

Placebo DIETARY_SUPPLEMENT

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

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• Solvitae Medical, S.L: collaborator
• University of Jaén: collaborator

Study Sites (1)

University of Jaén

Jaén, 23071, Spain

Location

Related Publications (1)

• de la Cruz Cazorla S, Blanco S, Rus A, Molina-Ortega FJ, Ocana E, Hernandez R, Visioli F, Moral MLD. Nutraceutical Supplementation as a Potential Non-Drug Treatment for Fibromyalgia: Effects on Lipid Profile, Oxidative Status, and Quality of Life. Int J Mol Sci. 2024 Sep 14;25(18):9935. doi: 10.3390/ijms25189935.

  PMID: 39337423 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Inflammation; Thrombosis; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mª Luisa del Moral, MD

  University of Jaén

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: January 20, 2021
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

ES (1)