NCT04245592

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 19, 2020

Last Update Submit

January 25, 2020

Conditions

Fibromyalgia

Keywords

nutritional interventionolive oilnitric oxideinflammationcortisollipid profile

Outcome Measures

Primary Outcomes (16)

  • Nitric Oxide

    NO production will be indirectly quantified by measuring nitrate/nitrite and S-nitrose compounds (NOx) using an ozone chemiluminescence-based method.

    4 weeks

  • Cortisol

    Cortisol level will be determined in serum samples by a fluorescence polarization immunoassay using an AxSYM analyser

    2 weeks

  • IL-6

    Interleukin 6 will be analyzed by chemiluminescent immunoassay using the Access Immunoassay Systems (Beckman Coulter)

    2 weeks

  • Lipid peroxidation

    Quantitation of thiobarbituric acid reactive substances (TBARS) presence

    2 weeks

  • IL-10

    Levels of IL-10 will be measured by a chemiluminescent immunoenzymatic assay using an MLX™ luminometer (Dynex Technologies, Chantilly, VA).

    2 weeks

  • C-Reactive Protein

    CRP will be measured using an AU 5800 analyzer (Beckman Coulter).

    2 weeks

  • Lipid Profile

    Serum lipid profile (total cholesterol, high-density lipoprotein \[HDL\]-cholesterol, triglycerides, apolipoprotein A1, and apolipoprotein B) will be measured by a spectrophotometric procedure using an OLYMPUS AU 5400 analyzer (Beckman Coulter). Low-density lipoprotein (LDL)-cholesterol levels will be estimated indirectly with the Friedewald equation. The level of homocysteine will be determined by a fluorescence polarization immunoassay using an AxSYM analyzer (Abbott Laboratories)

    2 weeks

  • Fibrinogen

    Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Prothrombin activity

    Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Cephaline time

    Will be determined in plasma samples using the BCS XP analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Platelet count

    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Platelet distribution width [PDW]

    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Mean platelet volume [MPV]

    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Red blood cell (RBC)

    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Neutrophil count

    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

  • Lymphocyte counts

    Will be measured in plasma samples by flow cytometry using the ADVIA 2120 analyzer (Siemens Healthineers, Erlangen, Germany).

    2 weeks

Study Arms (2)

Extra Virgin Olive Oil

EXPERIMENTAL

Women with fibromyalgia will consume Extra Virgin Olive Oil.

Dietary Supplement: Extra Virgin Olive Oil

Refined Olive Oil

EXPERIMENTAL

Women with fibromyalgia will consume Refined Olive Oil.

Dietary Supplement: Refined Olive Oil

Interventions

Extra Virgin Olive OilDIETARY_SUPPLEMENT

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.

Extra Virgin Olive Oil
Refined Olive OilDIETARY_SUPPLEMENT

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.

Refined Olive Oil

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with fibromyalgia will be previously diagnosed with fibromyalgia by a professional rheumatologist and met the American College of Rheumatology (ACR) criteria for fibromyalgia.

You may not qualify if:

  • Presence of any other chronic disease (diabetes mellitus, hypertension, rheumatoid arthritis, hepatitis, cancer or ischemic heart disease)
  • Smokers
  • Dyslipidemia
  • Pregnancy
  • Lactation
  • Grade II obesity (BMI ≥ 35 kg/m2)
  • Under anticoagulant, corticosteroid, estrogen, analgesic or anti-inflammatory treatment (or they have stopped using them at least 2 months before the start of our study).).
  • Patients who consume alcohol regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Molina Ortega

Jaén, 23009, Spain

Location

Related Publications (2)

  • Gassio R, Artuch R, Vilaseca MA, Fuste E, Colome R, Campistol J. Cognitive functions and the antioxidant system in phenylketonuric patients. Neuropsychology. 2008 Jul;22(4):426-31. doi: 10.1037/0894-4105.22.4.426.

    PMID: 18590354BACKGROUND

  • Rus A, Peinado MA, Blanco S, Del Moral ML. Is endothelial-nitric-oxide-synthase-derived nitric oxide involved in cardiac hypoxia/reoxygenation-related damage? J Biosci. 2011 Mar;36(1):69-78. doi: 10.1007/s12038-011-9006-4.

    PMID: 21451249BACKGROUND

MeSH Terms

Conditions

FibromyalgiaInflammation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • María Luisa Del Moral, MD

    University of Jaen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Patients were blinded to the kind of olive oil consumed using unlabeled bottles. A coding number in the blood samples of the patients were used to blind the Investigators.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 29, 2020

Study Start

January 15, 2020

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)