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

NCT06804460 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-02-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Universidad Francisco de Vitoria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-04-14
Completion
2025-04-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06804460 on ClinicalTrials.gov