FibromyalgiaPhase 1FIBROVEGNCT06804460
Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia
A Phase 1 study testing Dietary intervention in people with Fibromyalgia, run by Universidad Francisco de Vitoria.
Trial summary
This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 21 Apr 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged between 18 and 50 years.
- Participants with a Fibromyalgia diagnosis according to the American College of Rheumatology (ACR) criteria.
- Functional independence.
- Non-smokers.
- Low alcohol consumption (<1 serving/day).
- Pharmacological treatment stabilized for at least 4 weeks prior to the start of the study.
Who cannot join
- Pregnant, lactating, or menopausal women.
- Physical condition that prevents the performance of functional capacity tests.
- Change in pharmacological therapy during the intervention period.
- Concomitant inflammatory conditions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia.
Read the detailed description
The study involves two visits to the Exercise Physiology Research Laboratory at UFV. During the first visit, participants will complete functional capacity tests, respond to questionnaires (Fibromyalgia Impact Questionnaire, Short Form-36, MDF-Fibro-17, and Tampa Scale for Kinesiophobia), and provide a blood sample from the antecubital vein collected by an auxiliary nurse from the Eurofins MEGALABS laboratory. The biochemical markers to be analyzed include: white blood cell count (neutrophils, lymphocytes, monocytes, and platelets), lipid profile, fasting blood glucose levels and acute-phase proteins (C-reactive protein). Additionally, body composition will be assessed using a Tanita TBF300, and waist circumference will be measured. Functional capacity tests will include a handgrip strength test, a 30-second chair-to-stand test, and a timed up-and-go test. Participants will undergo a six-week dietary intervention and will return for a second visit at the end of the intervention period. They will be randomly assigned to follow either a vegan Mediterranean diet or a traditional Mediterranean diet, both of which will be guided and supervised by registered dietitians. These diets will be designed to meet individual energy needs and key nutrient requirements, following the standards set by the National Academy of Medicine and the Academy of Nutrition and Dietetics. Both diets will be isocaloric and maintain an identical macronutrient distribution. After the intervention, participants will repeat the same functional tests, questionnaires, and capillary blood measurements.
- Conditions
- Fibromyalgia
- Being tested
- Dietary intervention
- Keywords
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
The vegan mediterranean diet is mainly composed of whole plant-based foods, similar a una dieta mediterránea, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet.
| Study group | Role | What they receive |
|---|---|---|
| Vegan Mediterranean diet | Experimental | The vegan mediterranean diet is mainly composed of whole plant-based foods, similar to a Mediterranean diet, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet. Receives: Behavioral: Dietary intervention |
| Mediterranean diet | Active comparator | The traditional Mediterranean diet contains an abundant intake of whole plant-based foods, with moderate to low consumption of fish, poultry, low-fat dairy products, and eggs, very low consumption of red and processed meats, and no sweets. Olive oil is the main added fat, and animal protein accounts for 60% of total protein intake. Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil to lymphocyte ratio
Lymphocyte and neutrophil concentrations will be measured with the HemoCue® WBC DIFF system (HemoCue AB, Ängelholm, Sweden).The Neutrophil-to-Lymphocyte Ratio (NLR) is a simple inflammatory biomarker calculated by dividing neutrophil count by lymphocyte count. It reflects the balance between inflammation (neutrophils) and immune regulation (lymphocytes).
An elevated NLR is associated with chronic inflammation, physiological stress, or immune dysfunction, while lower levels indicate a more balanced immune state. Its ease of measurement and broad applicability make it valuable for monitoring inflammatory, cardiovascular, and oncological conditions.
Measured: From enrollment to the end of treatment at 6 weeks
Lipid profile
The concentrations of total cholesterol and cholesterol-LDL will be measured with a POC multi-parameter lux meter (Biochemical Systems International, Italy).
Measured: From enrollment to the end of treatment at 6 weeks
Cardiorespiratory fitness
The 30s Chair-to-Stand (CS) test assesses lower trunk strength by counting how many times a person can stand up and sit down within 30 seconds. It is commonly used to evaluate functional mobility and endurance in older adults or individuals with certain health conditions.
Measured: From enrollment to the end of treatment at 6 weeks
Quality life
The Fibromyalgia Impact Questionnaire (FIQ) examines the impact of fibromyalgia on daily life, covering areas such as functional capacity, pain, fatigue, sleep, and psychological well-being. Its revised version (FIQ-revised) focuses more on functional capacity, symptoms, and the overall impact of fibromyalgia on the individual's daily life.
Measured: From enrollment to the end of treatment at 6 weeks
Metabolic health
Visceral fat is the fat stored within the abdominal cavity around internal organs. It is commonly measured to assess the risk of metabolic diseases, such as type 2 diabetes and cardiovascular conditions.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (5)
Metabolic health
Fasting blood glucose measures the level of glucose in the blood after an overnight fast. It is used to assess insulin sensitivity and diagnose conditions like diabetes or prediabetes.
Measured: From enrollment to the end of treatment at 6 weeks
Metabolic health
Triglycerides are a type of fat (lipid) found in the blood, and their concentration is measured to assess cardiovascular health. High levels of triglycerides can increase the risk of heart disease and other metabolic conditions.
Measured: From enrollment to the end of treatment at 6 weeks
Strength performance
handgrip strength test evaluate the strength of the hand and forearm muscles. It is commonly used as an indicator of overall muscle strength and functional capacity.
Measured: From enrollment to the end of treatment at 6 weeks
Quality Life
The Tampa Scale for Kinesiophobia (TSK) will assess the degree of fear of movement or re-injury in individuals with pain or injury. The scale ranges from 17 (minimum) to 68 (maximum) points, with higher scores indicating a worse outcome, as they reflect greater fear of movement or re-injury. This tool helps understand how fear of movement can affect recovery and physical function.
Measured: From enrollment to the end of treatment at 6 weeks
Quality life
The Pittsburgh Sleep Quality Index assesses the quality and patterns of sleep over a one-month period. It is commonly used to evaluate sleep disturbances and their impact on overall health and well-being.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion14 Apr 2025 (estimated)
- Study completion21 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel López Moreno, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804460
- Sponsor's protocol ID
- AGL-2024-46 project
- Acronym
- FIBROVEG
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our study, the sharing of individual participant data (IPD) is not required as part of the trial registration process on ClinicalTrials.gov. The study does not involve sharing identifiable participant information or IPD for secondary analyses or public access
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia
- ClinicalTrials.gov ID
- NCT06804460
- Acronym / sponsor ID
- FIBROVEG / AGL-2024-46 project
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 14 Apr 2025 (estimated)
- Study completion
- 21 Apr 2025 (estimated)
- First posted
- 3 Feb 2025 (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.
This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia.
Detailed description
The study involves two visits to the Exercise Physiology Research Laboratory at UFV. During the first visit, participants will complete functional capacity tests, respond to questionnaires (Fibromyalgia Impact Questionnaire, Short Form-36, MDF-Fibro-17, and Tampa Scale for Kinesiophobia), and provide a blood sample from the antecubital vein collected by an auxiliary nurse from the Eurofins MEGALABS laboratory. The biochemical markers to be analyzed include: white blood cell count (neutrophils, lymphocytes, monocytes, and platelets), lipid profile, fasting blood glucose levels and acute-phase proteins (C-reactive protein). Additionally, body composition will be assessed using a Tanita TBF300, and waist circumference will be measured. Functional capacity tests will include a handgrip strength test, a 30-second chair-to-stand test, and a timed up-and-go test. Participants will undergo a six-week dietary intervention and will return for a second visit at the end of the intervention period. They will be randomly assigned to follow either a vegan Mediterranean diet or a traditional Mediterranean diet, both of which will be guided and supervised by registered dietitians. These diets will be designed to meet individual energy needs and key nutrient requirements, following the standards set by the National Academy of Medicine and the Academy of Nutrition and Dietetics. Both diets will be isocaloric and maintain an identical macronutrient distribution. After the intervention, participants will repeat the same functional tests, questionnaires, and capillary blood measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Mediterranean diet | Experimental | Behavioral: Dietary interventionThe vegan mediterranean diet is mainly composed of whole plant-based foods, similar to a Mediterranean diet, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet. |
| Mediterranean diet | Active comparator | Behavioral: Dietary interventionThe traditional Mediterranean diet contains an abundant intake of whole plant-based foods, with moderate to low consumption of fish, poultry, low-fat dairy products, and eggs, very low consumption of red and processed meats, and no sweets. Olive oil is the main added fat, and animal protein accounts for 60% of total protein intake. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 50 years.
- Participants with a Fibromyalgia diagnosis according to the American College of Rheumatology (ACR) criteria.
- Functional independence.
- Non-smokers.
- Low alcohol consumption (<1 serving/day).
Key exclusion criteria (4 listed)
- Pregnant, lactating, or menopausal women.
- Physical condition that prevents the performance of functional capacity tests.
- Change in pharmacological therapy during the intervention period.
- Concomitant inflammatory conditions.
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 |
|---|---|---|
| Dietary interventionThe vegan mediterranean diet is mainly composed of whole plant-based foods, similar a una dieta mediterránea, but the animal sources of protein and fat are substituted with plant foods rich in protein and fat. During the vegan diet, participants are supplemented with 1000 µg of cyanocobalamin (vitamin B12) twice a week (Harrison Sports Nutrition, Granada, Spain) to compensate for the deficiency in vitamin B12 intake induced by the vegan diet. | Behavioural | Mediterranean diet, Vegan Mediterranean diet |
Primary outcome
Neutrophil to lymphocyte ratio
Time frame: From enrollment to the end of treatment at 6 weeks
Lymphocyte and neutrophil concentrations will be measured with the HemoCue® WBC DIFF system (HemoCue AB, Ängelholm, Sweden).The Neutrophil-to-Lymphocyte Ratio (NLR) is a simple inflammatory biomarker calculated by dividing neutrophil count by lymphocyte count. It reflects the balance between inflammation (neutrophils) and immune regulation (lymphocytes). An elevated NLR is associated with chronic inflammation, physiological stress, or immune dysfunction, while lower levels indicate a more balanced immune state. Its ease of measurement and broad applicability make it valuable for monitoring inflammatory, cardiovascular, and oncological conditions.
Lipid profile
Time frame: From enrollment to the end of treatment at 6 weeks
The concentrations of total cholesterol and cholesterol-LDL will be measured with a POC multi-parameter lux meter (Biochemical Systems International, Italy).
Cardiorespiratory fitness
Time frame: From enrollment to the end of treatment at 6 weeks
The 30s Chair-to-Stand (CS) test assesses lower trunk strength by counting how many times a person can stand up and sit down within 30 seconds. It is commonly used to evaluate functional mobility and endurance in older adults or individuals with certain health conditions.
Quality life
Time frame: From enrollment to the end of treatment at 6 weeks
The Fibromyalgia Impact Questionnaire (FIQ) examines the impact of fibromyalgia on daily life, covering areas such as functional capacity, pain, fatigue, sleep, and psychological well-being. Its revised version (FIQ-revised) focuses more on functional capacity, symptoms, and the overall impact of fibromyalgia on the individual's daily life.
Metabolic health
Time frame: From enrollment to the end of treatment at 6 weeks
Visceral fat is the fat stored within the abdominal cavity around internal organs. It is commonly measured to assess the risk of metabolic diseases, such as type 2 diabetes and cardiovascular conditions.
5 secondary outcomes
Metabolic health
Time frame: From enrollment to the end of treatment at 6 weeks
Metabolic health
Time frame: From enrollment to the end of treatment at 6 weeks
Strength performance
Time frame: From enrollment to the end of treatment at 6 weeks
Quality Life
Time frame: From enrollment to the end of treatment at 6 weeks
Quality life
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No. In our study, the sharing of individual participant data (IPD) is not required as part of the trial registration process on ClinicalTrials.gov. The study does not involve sharing identifiable participant information or IPD for secondary analyses or public access
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dietary intervention in people with Fibromyalgia, run by Universidad Francisco de Vitoria.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel Dr. López Moreno, PhD ((+34) 647892334, miguel.lopez@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil to lymphocyte ratio (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.