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Fibromyalgia and Olive Oil

NCT04245592 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-29

No results posted yet for this study

Summary

We have recently reported a prothrombotic state in patients with fibromyalgia that may increase the risk of thrombosis-related cardiovascular disease in these patients. Several studies have shown the cardioprotective, antithrombotic and antiinflammatory properties of olive oil. The objective of the study is to investigate the effect of consumption of two types of olive oils with different antioxidant content on thrombosis-related parameters, nitric oxide, inflammation, lipid profile and cortisol as well as on health-related parameters in women with fibromyalgia.

Conditions

  • Fibromyalgia

Interventions

DIETARY_SUPPLEMENT

Extra Virgin Olive Oil

Before beginning the 3-week dietary trial, participants will conduct a 2-week washout period during which they consumed ROO (50 ml daily for 2 weeks) because they are part of a population that consumes olive oil regularly. After thar, patients of this groups will consume 50 ml/day of organic EVOO for 3 weeks. Biochemical markers and clinical parameters in each participant will be determine before and after the 3-week treatment period.

DIETARY_SUPPLEMENT

Refined Olive Oil

Before beginning the 3-week dietary trial, participants will conduct a 2-week washout period during which they consumed ROO (50 ml daily for 2 weeks) because they are part of a population that consumes olive oil regularly. After thar, patients of this groups will consume 50 ml/day of ROO for 3 weeks. Biochemical markers and clinical parameters in each participant will be determine before and after the 3-week treatment period.

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV

  • University of Jaén

    lead OTHER

Principal Investigators

  • María Luisa Del Moral, MD · University of Jaen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245592 on ClinicalTrials.gov