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.
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.
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.
Parallel
Dietary intervention
BehavioralThe 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.
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.
Lipid profile
The concentrations of total cholesterol and cholesterol-LDL will be measured with a POC multi-parameter lux meter (Biochemical Systems International, Italy).
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.
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.
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.
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.
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.
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.
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