Tool for Fibromyalgia Diagnosis and Effect of Extra Virgin Olive Oil

NCT05921409 | Unknown

• 2 other identifiers: IDI20210749IDI-20210749
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

PRONACERA THERAPEUTICS S.L. is a young biotechnological company focused on the development of genetic diagnostic tools and treatments for pathologies in different medical areas such as reproduction, fibromyalgia and rare diseases or with deficiencies in diagnosis, with the aim of helping to optimize health systems through improvement in terms and forms of diagnosis. Among the multiple lines of R+D+i that are currently being developed, the reproductive genomic line and endometrial functional molecular biology stand out. Specifically, it develops the design of markers and performs the genetic analysis of infertility focused on female endometrial tissue. Fibromyalgia is a complex and common chronic pain disorder that affects 12 million Europeans. Along with other symptoms, fibromyalgia causes pain and general tenderness to touch. Currently this disease is diagnosed following the criteria established by the American College of Rheumatology (ACR) of a combination of relevant symptoms and the description of how the person feels. In other words, in practice it is a diagnosis by elimination. A patient suffering from fibromyalgia usually takes between 2 to 3 years to obtain the correct diagnosis. Health experts consider that fibromyalgia is a disease that is difficult to diagnose and that is associated with an expensive use of health system services. With FIBROKIT, Pronacera aims to design and develop a new diagnostic and monitoring tool for fibromyalgia by designing a panel of specific plasma proteome and intestinal microbiome biomarkers and reducing the number of biological samples used. During the execution of this project, the company will have three leading research and innovation organizations in the sector (Helix BioS, CINUSA and CICbioGUNE) that will support Pronacera. FIBROKIT will have a cohort of 250 participants (206 patients and 44 healthy volunteers) to validate the diagnostic capacity of the tool and perform a robust biostatistical study.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Olive oil; Nutrition; Mediterranean diet; Proteomics; Metagenomics; Microbiome

Outcome Measures

Primary Outcomes (16)

• Concentration of Voltage dependent anion channel 1 protein (VDAC)

  VDAC protein determination by western blot

  0 weeks

• Concentration of Voltage dependent anion channel 1 protein (VDAC)

  VDAC protein determination by western blot

  12 weeks

• Concentration of Voltage dependent anion channel 1 protein (VDAC)

  VDAC protein determination by western blot

  24 weeks

• Concentration of Voltage dependent anion channel 1 protein (VDAC)

  VDAC protein determination by western blot

  48 weeks

• Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)

  LC3B protein determination by western blot

  0 weeks

• Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)

  LC3B protein determination by western blot

  12 weeks

• Microtubule-associated proteins 1B light chain 3B (LC3B)

  LC3B protein determination by western blot

  24 weeks

• Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)

  LC3B protein determination by western blot

  48 weeks

• Concentration of Plasma Proteins

  Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion

  0 weeks

• Concentration of Plasma Proteins

  Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion

  12 weeks

• Concentration of Plasma Proteins

  Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion

  24 weeks

• Concentration of Plasma Proteins

  Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion

  48 weeks

• Abundance of Bacteria from the Intestinal Microbiome

  Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene

  0 weeks

• Abundance of Bacteria from the Intestinal Microbiome

  Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene

  12 weeks

• Abundance of Bacteria from the Intestinal Microbiome

  Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene

  24 weeks

• Abundance of Bacteria from the Intestinal Microbiome

  Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene

  48 weeks

Secondary Outcomes (8)

• 36-Item Short Form Health Survey (SF-36) Score

  0 weeks

• 36-Item Short Form Health Survey (SF-36) Score

  12 weeks

• 36-Item Short Form Health Survey (SF-36) Score

  24 weeks

• 36-Item Short Form Health Survey (SF-36) Score

  48 weeks

• Fibromyalgia Impact Questionnaire (FIQ) Score

  0 weeks

Study Arms (2)

MED DIET + AOVE

EXPERIMENTAL

A six-months nutritional intervention with a Mediterranean diet, daily supplemented with 50 ml of extra virgin olive oil. The intake of the oil was divided in the main meals and needed to be consumed without cooking.

Dietary Supplement: Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention

MED DIET + AO

PLACEBO COMPARATOR

A six-months nutritional intervention with a Mediterranean diet, daily supplemented with 50 ml of olive oil. The intake of the oil was divided in the main meals and needed to be consumed without cooking.

Dietary Supplement: Olive oil-supplemented Mediterranean Diet Intervention

Interventions

Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention DIETARY_SUPPLEMENT

This intervention (treatment) consist of taking Extra Virgin Olive Oil ("treatment" group made up of 103 patients and 22 healthy people) for 6 months, accompanied by Mediterranean diet-based menus. During this time, blood and stool samples were taken at different points: before the start of the intervention (T0), 3 months after the start (T1), at the end of the intervention in the sixth month (T2) and 6 months after leaving the study (TF). Hence, a total of 4 time points were taken for analysis: T0, T1, T2, TF. Additionally, and following these same time points, the physical and psychological health status of the participants will be evaluated using the SF-36 health questionnaire. Similarly, the course of the pathology in terms of the Fibromyalgia Impact Questionnaire (FIQ) score were recorded.

MED DIET + AOVE

Olive oil-supplemented Mediterranean Diet Intervention DIETARY_SUPPLEMENT

This intervention (treatment) consist of taking Olive Oil ("placebo" group made up of 103 patients and 22 healthy people) for 6 months, accompanied by Mediterranean diet-based menus. During this time, blood and stool samples were taken at different points: before the start of the intervention (T0), 3 months after the start (T1), at the end of the intervention in the sixth month (T2) and 6 months after leaving the study (TF). Hence, a total of 4 time points were taken for analysis: T0, T1, T2, TF. Additionally, and following these same time points, the physical and psychological health status of the participants will be evaluated using the SF-36 health questionnaire. Similarly, the course of the pathology in terms of the Fibromyalgia Impact Questionnaire (FIQ) score were recorded.

MED DIET + AO

Eligibility Criteria

• Age: 40 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 40 and 59 years

You may not qualify if:

• Follow a balanced diet in terms of the food source (fruits, vegetables, legumes, meat, fish, etc.).
• Being outside the established age range (40-59) at the time of the start of the study
• Have practiced some type of structured or planned physical activity more than 2 times a week during the last month, such as:
• Go to collective classes of Yoga, Tai-Chi, Zumba, dance, gymnastics or similar
• Going for a walk, cycling, hiking or similar for 30 minutes or more than 10,000 steps per day
• Being underweight (BMI \< 18.5) or type II or higher obesity (BMI \> 34.9)
• Suffer and have been diagnosed with any of the following chronic pathologies:
• any type of cancer
• Acquired Immunodeficiency Syndrome (AIDS)
• Inflammatory diseases (rheumatoid arthritis, osteoarthritis)
• Gastrointestinal diseases (Crohn's disease, ulcerative colitis)
• Cardiovascular diseases (atherosclerosis, cardiomyopathy, stroke)
• Autoimmune diseases (systemic lupus erythematosus, celiac disease, Hashimoto's thyroiditis, multiple sclerosis)
• Metabolic diseases (Type I and II Diabetes, Metabolic Syndrome)
• Having been under intensive pharmacological treatment (3 or more drugs daily) with non-steroidal anti-inflammatory drugs, corticosteroids, analgesics, or antidepressants during the month prior to the start of the study.

Sponsors & Collaborators

• Pronacera Therapeutics SL: lead
• Centre for the Development of Industrial Technology, Spain: collaborator

Study Sites (1)

Pronacera Therapeutics Laboratory

Seville, 41015, Spain

Location

Related Publications (6)

• Martinez-Lara A, Moreno-Fernandez AM, Jimenez-Guerrero M, Diaz-Lopez C, De-Miguel M, Cotan D, Sanchez-Alcazar JA. Mitochondrial Imbalance as a New Approach to the Study of Fibromyalgia. Open Access Rheumatol. 2020 Aug 24;12:175-185. doi: 10.2147/OARRR.S257470. eCollection 2020.

  PMID: 32922097 BACKGROUND

• Ramirez-Tejero JA, Martinez-Lara E, Rus A, Camacho MV, Del Moral ML, Siles E. Insight into the biological pathways underlying fibromyalgia by a proteomic approach. J Proteomics. 2018 Aug 30;186:47-55. doi: 10.1016/j.jprot.2018.07.009. Epub 2018 Jul 17.

  PMID: 30030163 BACKGROUND

• Minerbi A, Fitzcharles MA. Gut microbiome: pertinence in fibromyalgia. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):99-104. Epub 2020 Feb 12.

  PMID: 32116215 BACKGROUND

• Clos-Garcia M, Andres-Marin N, Fernandez-Eulate G, Abecia L, Lavin JL, van Liempd S, Cabrera D, Royo F, Valero A, Errazquin N, Vega MCG, Govillard L, Tackett MR, Tejada G, Gonzalez E, Anguita J, Bujanda L, Orcasitas AMC, Aransay AM, Maiz O, Lopez de Munain A, Falcon-Perez JM. Gut microbiome and serum metabolome analyses identify molecular biomarkers and altered glutamate metabolism in fibromyalgia. EBioMedicine. 2019 Aug;46:499-511. doi: 10.1016/j.ebiom.2019.07.031. Epub 2019 Jul 18.

  PMID: 31327695 BACKGROUND

• Duran-Gonzalez E, Ramirez-Tejero JA, Perez-Sanchez M, Morales-Torres C, Gomez-Morano R, Diaz-Lopez C, Martinez-Lara A, Cotan D. Fibromyalgia diagnosis from a multi-omics approach: a gut feeling. Front Microbiol. 2025 Oct 2;16:1641185. doi: 10.3389/fmicb.2025.1641185. eCollection 2025.

  PMID: 41113645 DERIVED

• Del Amo LL, Duran-Gonzalez E, Ramirez-Tejero JA, Martinez-Lara A, Cotan D. Study protocol for FIBROKIT: a new tool for fibromyalgia diagnosis and patient follow-up. Front Neurol. 2023 Nov 21;14:1286539. doi: 10.3389/fneur.2023.1286539. eCollection 2023.

  PMID: 38073622 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• José Antonio Sánchez Alcázar, MD

  Pablo de Olavide University, Seville (Spain)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment (extra virgin olive oil) and placebo (olive oil) were packed in 50 ml opaque envelopes for patients masking. Letters A and B were assigned randomly to each treatment by an external person not participating in the study design or analysis for investigator masking.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blinded, placebo controlled intervention

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: January 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)