Effects of Olive Polyphenols in Fibromyalgia Patients

University of Granada (UGR)

Status: Completed

Conditions: Fibromyalgia

Treatments: Dietary Supplement: Olive Polyphenols; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06348537

Polyphenol-Fibromyalgia

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Group 1

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Olive Polyphenols

Group 2

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo