FibromyalgiaFIBROKITNCT05921409
Tool for Fibromyalgia Diagnosis and Effect of Extra Virgin Olive Oil
A study testing Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention and Olive oil-supplemented Mediterranean Diet Intervention in people with Fibromyalgia, run by Pronacera Therapeutics SL at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention and Olive oil-supplemented Mediterranean Diet Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 40 and 59 years
- Do not carry out any type of guided and structured physical activity (detailed in the exclusion criteria)
- Follow a balanced diet in terms of the food source (fruits, vegetables, legumes, meat, fish, etc.).
Who cannot join
- 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:
Show all 17Show fewer
- 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.
- Being under antioxidant supplementation (Glutathione, Coenzyme Q10, plant extracts, phenolic compounds)
- Consuming an amount greater than 12 g/day of alcohol, admitted in the context of the Mediterranean diet (Willett et al., 1995).
- Smoking or consuming any type of narcotic substance (regardless of the amount and frequency)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a New Tool for the Diagnosis and Monitoring of Fibromyalgia "FIBROKIT"
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.
Read the detailed description
Fibromyalgia (FM) is a chronic syndrome characterized mainly by the presence of widespread pain. This pain is usually accompanied by other alterations, both physically and psychologically, which, ultimately, seriously compromise people's quality of life, affecting their family, social and work environment and causing high social-sanitary costs. Although different factors such as an imbalance at the oxidative level or control of the inflammatory response have been studied, to date it is not known exactly what molecular alteration is responsible for the appearance and development of FM. This situation makes extremely difficult the search for a curative treatment and a specific and accurate laboratory diagnosis. The concept of FIBROKIT was born with the intention of solving both shortcomings. Thus, the main objective of this project is to fully design the panel of specific biomarkers to use in FIBROKIT. To achieve this great objective, three specific objectives have been set:
- Design, based on new scientific evidence, the components of the molecular diagnostic panel focused on Peripheral Blood Mononuclear Cell-specific proteins, plasma proteome and intestinal microbiome biomarkers.
- Increase the number of patients participating in the study to validate the diagnostic capacity of the kit with robust statistics.
- Analytically validate the response of the new panel of molecular markers to the course of the pathology and its monitoring under a nutritional intervention with olive oil-supplemented mediterranean diet.
- Conditions
- Fibromyalgia
- Being tested
- Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention, Olive oil-supplemented Mediterranean Diet Intervention
- Keywords
- Fibromyalgia, Olive oil, Nutrition, Mediterranean diet, Proteomics, Metagenomics, Microbiome
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra Virgin Olive oil-supplemented Mediterranean Diet InterventionDietary 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.
Olive oil-supplemented Mediterranean Diet InterventionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Olive oil-supplemented Mediterranean Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Voltage dependent anion channel 1 protein (VDAC)
VDAC protein determination by western blot
Measured: 0 weeks
Concentration of Voltage dependent anion channel 1 protein (VDAC)
VDAC protein determination by western blot
Measured: 12 weeks
Concentration of Voltage dependent anion channel 1 protein (VDAC)
VDAC protein determination by western blot
Measured: 24 weeks
Concentration of Voltage dependent anion channel 1 protein (VDAC)
VDAC protein determination by western blot
Measured: 48 weeks
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
LC3B protein determination by western blot
Measured: 0 weeks
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
LC3B protein determination by western blot
Measured: 12 weeks
Microtubule-associated proteins 1B light chain 3B (LC3B)
LC3B protein determination by western blot
Measured: 24 weeks
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
LC3B protein determination by western blot
Measured: 48 weeks
Concentration of Plasma Proteins
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Measured: 0 weeks
Concentration of Plasma Proteins
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Measured: 12 weeks
Concentration of Plasma Proteins
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Measured: 24 weeks
Concentration of Plasma Proteins
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 weeks
Secondary outcomes (8)
36-Item Short Form Health Survey (SF-36) Score
36-Item Short Form Health Survey score
Measured: 0 weeks
36-Item Short Form Health Survey (SF-36) Score
36-Item Short Form Health Survey score
Measured: 12 weeks
36-Item Short Form Health Survey (SF-36) Score
36-Item Short Form Health Survey score
Measured: 24 weeks
36-Item Short Form Health Survey (SF-36) Score
36-Item Short Form Health Survey score
Measured: 48 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Fibromyalgia Impact Questionnaire (FIQ) score
Measured: 0 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Fibromyalgia Impact Questionnaire (FIQ) score
Measured: 12 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Fibromyalgia Impact Questionnaire (FIQ) score
Measured: 24 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Fibromyalgia Impact Questionnaire (FIQ) score
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jan 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blinded, placebo controlled intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronacera Therapeutics SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for the Development of Industrial Technology, Spain
- Responsible party
- Sponsor
- Investigators
- José Antonio Sánchez Alcázar, MD, Study chair, Pablo de Olavide University, Seville (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921409
- Sponsor's protocol ID
- IDI20210749
- Other IDs
- IDI-20210749
- Acronym
- FIBROKIT
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32922097Ramirez-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.
PubMed 30030163Minerbi A, Fitzcharles MA. Gut microbiome: pertinence in fibromyalgia. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):99-104. Epub 2020 Feb 12.
PubMed 32116215Clos-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.
PubMed 31327695Duran-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.
PubMed 41113645Del 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.
PubMed 38073622
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Tool for the Diagnosis and Monitoring of Fibromyalgia "FIBROKIT"
- ClinicalTrials.gov ID
- NCT05921409
- Acronym / sponsor ID
- FIBROKIT / IDI20210749
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Olive oil, Nutrition, Mediterranean diet, Proteomics, Metagenomics, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Pronacera Therapeutics SLIndustry (pharma, biotech, devices)
- Collaborators
- Centre for the Development of Industrial Technology, Spain
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia (FM) is a chronic syndrome characterized mainly by the presence of widespread pain. This pain is usually accompanied by other alterations, both physically and psychologically, which, ultimately, seriously compromise people's quality of life, affecting their family, social and work environment and causing high social-sanitary costs. Although different factors such as an imbalance at the oxidative level or control of the inflammatory response have been studied, to date it is not known exactly what molecular alteration is responsible for the appearance and development of FM. This situation makes extremely difficult the search for a curative treatment and a specific and accurate laboratory diagnosis. The concept of FIBROKIT was born with the intention of solving both shortcomings. Thus, the main objective of this project is to fully design the panel of specific biomarkers to use in FIBROKIT. To achieve this great objective, three specific objectives have been set:
- Design, based on new scientific evidence, the components of the molecular diagnostic panel focused on Peripheral Blood Mononuclear Cell-specific proteins, plasma proteome and intestinal microbiome biomarkers.
- Increase the number of patients participating in the study to validate the diagnostic capacity of the kit with robust statistics.
- Analytically validate the response of the new panel of molecular markers to the course of the pathology and its monitoring under a nutritional intervention with olive oil-supplemented mediterranean diet.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blinded, placebo controlled intervention
| Arm | Type | Receives |
|---|---|---|
| MED DIET + AOVE | Experimental | Dietary Supplement: Extra Virgin Olive oil-supplemented Mediterranean Diet InterventionA 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. |
| MED DIET + AO | Placebo comparator | Dietary Supplement: Olive oil-supplemented Mediterranean Diet InterventionA 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. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between 40 and 59 years
- Do not carry out any type of guided and structured physical activity (detailed in the exclusion criteria)
- Follow a balanced diet in terms of the food source (fruits, vegetables, legumes, meat, fish, etc.).
Key exclusion criteria (17 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra Virgin Olive oil-supplemented Mediterranean Diet InterventionThis 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. | Dietary supplement | MED DIET + AOVE |
| Olive oil-supplemented Mediterranean Diet InterventionThis 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. | Dietary supplement | MED DIET + AO |
Primary outcome
Concentration of Voltage dependent anion channel 1 protein (VDAC)
Time frame: 0 weeks
VDAC protein determination by western blot
Concentration of Voltage dependent anion channel 1 protein (VDAC)
Time frame: 12 weeks
VDAC protein determination by western blot
Concentration of Voltage dependent anion channel 1 protein (VDAC)
Time frame: 24 weeks
VDAC protein determination by western blot
Concentration of Voltage dependent anion channel 1 protein (VDAC)
Time frame: 48 weeks
VDAC protein determination by western blot
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
Time frame: 0 weeks
LC3B protein determination by western blot
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
Time frame: 12 weeks
LC3B protein determination by western blot
Microtubule-associated proteins 1B light chain 3B (LC3B)
Time frame: 24 weeks
LC3B protein determination by western blot
Concentration of Microtubule-associated proteins 1B light chain 3B (LC3B)
Time frame: 48 weeks
LC3B protein determination by western blot
Concentration of Plasma Proteins
Time frame: 0 weeks
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Concentration of Plasma Proteins
Time frame: 12 weeks
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Concentration of Plasma Proteins
Time frame: 24 weeks
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Concentration of Plasma Proteins
Time frame: 48 weeks
Plasma proteome Analysis by label-free nano Liquid Chromatography coupled to tandem mass spectrometry after top-14 depletion
Abundance of Bacteria from the Intestinal Microbiome
Time frame: 0 weeks
Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene
Abundance of Bacteria from the Intestinal Microbiome
Time frame: 12 weeks
Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene
Abundance of Bacteria from the Intestinal Microbiome
Time frame: 24 weeks
Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene
Abundance of Bacteria from the Intestinal Microbiome
Time frame: 48 weeks
Fecal metagenomic analysis by amplicon sequencing of hypervariable region V3-V4 from RNA 16S bacterial gene
8 secondary outcomes
36-Item Short Form Health Survey (SF-36) Score
Time frame: 0 weeks
36-Item Short Form Health Survey (SF-36) Score
Time frame: 12 weeks
36-Item Short Form Health Survey (SF-36) Score
Time frame: 24 weeks
36-Item Short Form Health Survey (SF-36) Score
Time frame: 48 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Time frame: 0 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Time frame: 12 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Time frame: 24 weeks
Fibromyalgia Impact Questionnaire (FIQ) Score
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 32922097Martinez-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.
- Background: PubMed 30030163Ramirez-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.
- Background: PubMed 32116215Minerbi A, Fitzcharles MA. Gut microbiome: pertinence in fibromyalgia. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):99-104. Epub 2020 Feb 12.
- Background: PubMed 31327695Clos-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.
- Derived from this study: PubMed 41113645Duran-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.
- Derived from this study: PubMed 38073622Del 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.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Antonio Sánchez Alcázar, MD study chair
Pablo de Olavide University, Seville (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra Virgin Olive oil-supplemented Mediterranean Diet Intervention and Olive oil-supplemented Mediterranean Diet Intervention in people with Fibromyalgia, run by Pronacera Therapeutics SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Voltage dependent anion channel 1 protein (VDAC) (time frame: 0 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921409, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.