NCT Number: NCT06804460
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.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Phase 1
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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.
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Contact information is provided by the study sponsor or research team.
Universidad Francisco de Vitoria
Other
Acronym: FIBROVEG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738926
Fibromyalgia, Fibromyalgia Syndrome
Genova, Italy
View Trial DetailsNCT07722923
Fibromyalgia, Muscular Diseases
View Trial DetailsNCT07611539
Fibromyalgia, Muscular Diseases
View Trial DetailsNCT07680621
Fibromyalgia, Muscular Diseases
Sakarya, Turkey (Türkiye)
View Trial Details