FibromyalgiaNCT06348537
Effects of Olive Polyphenols in Fibromyalgia Patients
A study testing Olive Polyphenols in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial summary
To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Olive Polyphenols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2021to 1 Sep 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Potential of Olive Polyphenols in Fibromyalgia Management
To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.
Read the detailed 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.
- Conditions
- Fibromyalgia
- Being tested
- Olive Polyphenols, Placebo
- Keywords
- olive polyphenol, Oxidative stress, Inflammation, coagulation, pain, proteomics
- Medical subject headings
- Fibromyalgia, Inflammation, Thrombosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive PolyphenolsDietary supplement
Patients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days.
PlaceboDietary supplement
Patients with fibromyalgia of Group 2 will consume a placebo daily during 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Dietary Supplement: Olive Polyphenols |
| Group 2 | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma proteome
Proteomic analyses will be performed by liquid nano-chromatography coupled to label-free tandem mass spectrometry (label-free nLC-MS/MS). This technique allows the relative quantification of the abundance of each protein in each sample, making it possible to assess those with differential expression in the different study groups.
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 3 months
Lipid peroxidation
Lipid peroxidation is determined by thiobarbituric acid reactive substances (TBARS) method.
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Secondary outcomes (11)
Aldolase
Aldolase is measured using an AU 5800 analyzer (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
C-reactive protein (CRP)
C-reactive protein (CRP) ie measured using an AU 5800 analyzer (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Impact of fibromyalgia
FIQR (Revised Fibromyalgia Impact Questionnaire) will be used to evaluate the functional capacity in daily living activities
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 20 minutes
Quality of Life
SF-12 (Quality of Life Questionnaire) is used to assess quality of life.
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 20 minutes
Red blood cells
Red blood cells are measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Haemoglobin
Haemoglobin is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Fibrinogen
Fibrinogen is measured using a DxH 900 Workcell Automated Hematology Solution (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Total cholesterol
Total cholesterol is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Cholesterol ratio
Cholesterol ratio is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
LDL cholesterol
LDL cholesterol is measured by a spectrophotometric procedure using an Olympus AU 5400 analyzer (Beckman Coulter).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Cortisol
Cortisol level is determined in serum samples by a fluorescence polarization immunoassay using an AxSYM (Abbott Laboratories, IL, USA).
Measured: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start20 Jan 2021
- Primary completion1 Apr 2021
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Solvitae Medical, S.L, University of Jaén
- Responsible party
- Principal investigator, ALMA RUS MARTÍNEZ, Universidad de Granada
- Investigators
- Mª Luisa del Moral, MD, Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348537
- Sponsor's protocol ID
- Polyphenol-Fibromyalgia
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de la Cruz Cazorla S, Blanco S, Rus A, Molina-Ortega FJ, Ocana E, Hernandez R, Visioli F, Moral MLD. Nutraceutical Supplementation as a Potential Non-Drug Treatment for Fibromyalgia: Effects on Lipid Profile, Oxidative Status, and Quality of Life. Int J Mol Sci. 2024 Sep 14;25(18):9935. doi: 10.3390/ijms25189935.
PubMed 39337423
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Potential of Olive Polyphenols in Fibromyalgia Management
- ClinicalTrials.gov ID
- NCT06348537
- Acronym / sponsor ID
- Polyphenol-Fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- olive polyphenol, Oxidative stress, Inflammation, coagulation, pain, proteomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Solvitae Medical, S.L, University of Jaén
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 4 Apr 2024 (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.
To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Olive PolyphenolsGroup 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. |
| Group 2 | Placebo comparator | Dietary Supplement: PlaceboGroup 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Olive PolyphenolsPatients with fibromyalgia of Group 1 will consume Olive Polyphenols daily during 60 days. | Dietary supplement | Group 1 |
| PlaceboPatients with fibromyalgia of Group 2 will consume a placebo daily during 60 days. | Dietary supplement | Group 2 |
Primary outcome
Plasma proteome
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 3 months
Proteomic analyses will be performed by liquid nano-chromatography coupled to label-free tandem mass spectrometry (label-free nLC-MS/MS). This technique allows the relative quantification of the abundance of each protein in each sample, making it possible to assess those with differential expression in the different study groups.
Lipid peroxidation
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Lipid peroxidation is determined by thiobarbituric acid reactive substances (TBARS) method.
11 secondary outcomes
Aldolase
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
C-reactive protein (CRP)
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Impact of fibromyalgia
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 20 minutes
Quality of Life
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 20 minutes
Red blood cells
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Haemoglobin
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Fibrinogen
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Total cholesterol
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Cholesterol ratio
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
LDL cholesterol
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Cortisol
Time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 39337423de la Cruz Cazorla S, Blanco S, Rus A, Molina-Ortega FJ, Ocana E, Hernandez R, Visioli F, Moral MLD. Nutraceutical Supplementation as a Potential Non-Drug Treatment for Fibromyalgia: Effects on Lipid Profile, Oxidative Status, and Quality of Life. Int J Mol Sci. 2024 Sep 14;25(18):9935. doi: 10.3390/ijms25189935.
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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.
Mª Luisa del Moral, MD principal investigator
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Polyphenols in people with Fibromyalgia, run by Universidad de Granada 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 4 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma proteome (time frame: It will be carried out on blood samples from the study participants before starting the intervention and at the end. Estimated duration of 3 months). The study lists 2 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 NCT06348537, which also lists 1 linked publication.
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 4 Apr 2024.