Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Neutrophil to lymphocyte ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dietary intervention (Behavioral)
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.
干预措施: Dietary intervention (Behavioral)
结局指标
主要结局
Neutrophil to lymphocyte ratio
时间窗: From enrollment to the end of treatment at 6 weeks
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.
Lipid profile
时间窗: From enrollment to the end of treatment at 6 weeks
The concentrations of total cholesterol and cholesterol-LDL will be measured with a POC multi-parameter lux meter (Biochemical Systems International, Italy).
Cardiorespiratory fitness
时间窗: From enrollment to the end of treatment at 6 weeks
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.
Quality life
时间窗: From enrollment to the end of treatment at 6 weeks
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.
Metabolic health
时间窗: From enrollment to the end of treatment at 6 weeks
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.
次要结局
- Strength performance(From enrollment to the end of treatment at 6 weeks)
- Metabolic health(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)
研究者
Miguel López Moreno
Principal Investigator
Universidad Francisco de Vitoria