Impact of a Mediterranean Diet-based Culinary Medicine Intervention on the Reversal of Metabolic Syndrome and Biomarkers of Inflammation, Oxidative Stress, and Aging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in metabolic syndrome components
研究概览
简要总结
Metabolic syndrome is a major public health concern associated with an increased risk of cardiovascular disease, type 2 diabetes, and premature mortality. The Mediterranean diet has consistently demonstrated beneficial effects on metabolic health and is recommended as a dietary strategy for the prevention and management of metabolic syndrome. However, most interventions have focused on conventional nutritional counseling and have paid limited attention to the culinary and gastronomic skills required to translate dietary recommendations into sustainable eating behaviors.
This randomized controlled trial will evaluate the effectiveness of a Mediterranean diet-based nutritional intervention complemented by culinary medicine training sessions compared with a nutritional intervention alone in Spanish adults with metabolic syndrome. The culinary medicine component is designed to enhance participants' food preparation skills, confidence in cooking, and ability to incorporate Mediterranean dietary principles into their daily lives.
Participants will be followed for 6 months to assess changes in metabolic syndrome components and other metabolic health indicators. The study aims to determine whether the integration of culinary medicine education enhances the effectiveness of conventional nutritional counseling in improving metabolic syndrome outcomes and promoting long-term adherence to a Mediterranean dietary pattern
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age between 30 and 60 years
- •Body mass index (BMI) between 20 and 35 kg/m²
- •Presence of metabolic syndrome defined as having at least three of the following criteria:
- •HDL cholesterol <40 mg/dL in men and <50 mg/dL in women
- •Fasting glucose >100 mg/dL or use of hypoglycemic agents
- •Triglycerides ≥150 mg/dL or use of lipid-lowering medication
- •Blood pressure ≥130/85 mmHg
- •Waist circumference ≥102 cm in men and ≥88 cm in women
排除标准
- •Food allergies or intolerances to foods typical of the Mediterranean diet
- •Gluten intolerance or celiac disease
- •Adherence to a vegetarian or vegan diet
- •Eating disorders (including anorexia nervosa, bulimia nervosa, and binge eating disorder)
- •Moderate to severe psychiatric disorders that may compromise adherence to the intervention
- •History of cardiovascular events
- •BMI >35 kg/m²
- •Extreme dietary patterns in the last 3 months (e.g., Atkins diet, very high-protein diets)
- •Excessive alcohol consumption (>30 g/day for men and >20 g/day for women)
- •Pregnancy or lactation
- •Previous culinary training or formal culinary education
研究组 & 干预措施
Culinary-Nutritional Intervention Group
干预措施: Mediterranean diet-based culinary intervention (Behavioral)
Control group
干预措施: Standard nutritional counseling (Behavioral)
结局指标
主要结局
Changes in metabolic syndrome components
时间窗: Baseline, 3 months, and 6 months
Changes in metabolic syndrome components according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria, including waist circumference, blood pressure, fasting glucose, triglycerides, and HDL cholesterol, measured as continuous variables, using a score ranging from 1 to 5.
次要结局
- Body weight, fat mass and lean mass(Baseline, 3 months, and 6 months)
- Body fat(Baseline, 3 months, and 6 months)
- Height(Baseline, 3 months, and 6 months)
- Lipid profile(Baseline, 3 months, and 6 months)
- Liver enzymes(Baseline, 3 months, and 6 months)
- Total and direct bilirubin(Baseline, 3 months, and 6 months)
- Serum albumin and total protein(Baseline, 3 months, and 6 months)
- Glycated hemoglobin(Baseline, 3 months, and 6 months)
- Dietary intake(Baseline, 3 months, and 6 months)
- Mediterranean diet adherence(Baseline, 3 months, and 6 months)
- Culinary habits(Baseline, 3 months, and 6 months)
研究者
Rosa Casas
Head of the Cardiovascular Risk, Nutrition and Aging Laboratory, Cardiovascular Risk Group
Fundacion Clinic per a la Recerca Biomédica