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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Neutrophil to lymphocyte ratio [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Lipid profile [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Cardiorespiratory fitness [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Quality life [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Metabolic health [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Вторичные конечные точки (5)

• Metabolic health [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Metabolic health [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Strength performance [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Quality Life [Срок оценки: From enrollment to the end of treatment at 6 weeks]
• Quality life [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06804460 · AGL-2024-46 project

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗