Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-02 @ 11:14 PM
Study NCT ID:
NCT06804460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia
Sponsor:
Universidad Francisco de Vitoria
Organization:
Study Overview
Official Title:
Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBROVEG
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: