Effects of Olive Polyphenols in Fibromyalgia Patients

NCT ID: NCT06348537

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2023-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

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 Type EXPERIMENTAL

Olive Polyphenols

Intervention Type DIETARY_SUPPLEMENT

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

Group 2

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Olive Polyphenols

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Solvitae Medical, S.L

UNKNOWN

Sponsor Role collaborator

University of Jaén

OTHER

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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ALMA RUS MARTÍNEZ

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mª Luisa del Moral, MD

Role: PRINCIPAL_INVESTIGATOR

University of Jaén

Locations

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University of Jaén

Jaén, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 39337423 (View on PubMed)

Other Identifiers

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Polyphenol-Fibromyalgia

Identifier Type: -

Identifier Source: org_study_id

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