NCT06804460

Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Universidad Francisco de Vitoria · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Dietary intervention	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-04-14
• Completion: 2025-04-21
• First posted: 2025-02-03
• Last updated: 2025-02-03