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

NCT ID: NCT06804460

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-04-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vegan Mediterranean diet

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.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: BEHAVIORAL

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.

Mediterranean diet

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.

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

Miguel López Moreno

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Miguel Dr. López Moreno, PhD

Role: CONTACT

miguel.lopez@ufv.es

(+34) 647892334

Other Identifiers

AGL-2024-46 project

Identifier Type: -

Identifier Source: org_study_id