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

NCT06804460 | Not Yet Recruiting Phase 1

• 1 other identifier: AGL-2024-46 project
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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.

  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.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (5)

• Metabolic health

  From enrollment to the end of treatment at 6 weeks

• Metabolic health

  From enrollment to the end of treatment at 6 weeks

• Strength performance

  From enrollment to the end of treatment at 6 weeks

• Quality Life

  From enrollment to the end of treatment at 6 weeks

• Quality life

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

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.

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.

Behavioral: Dietary intervention

Interventions

Dietary intervention 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; Vegan Mediterranean diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

MeSH Terms

Conditions

Fibromyalgia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Miguel Dr. López Moreno, PhD

CONTACT

(+34) 647892334; miguel.lopez@ufv.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 3, 2025
• Study Start: March 1, 2025
• Primary Completion: April 14, 2025
• Study Completion: April 21, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share