Prevention of Cardiovascular Disease With the Vegetarian Diet: the CARDIVEG Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Changes in Body Weight From Baseline
研究概览
简要总结
The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet would benefit the cardiovascular risk profile of the participants, compared with a Mediterranean diet.
详细描述
Nutrition is able to substantially alter the health status of the general population. In industrialized countries such as Italy the most important association between diet and health is certainly the relationship with cardiovascular disease, the leading cause of death and disability. The ability to identify with certainty, therefore, the relationship between diet and cardiovascular disease appears to be a key element in the implementation of specific primary prevention strategies.
Cardiovascular diseases would be the result of interactions between genetics and environmental factors. Many studies have evaluated the associations between food groups, foods, or nutrients and chronic diseases, and a consensus about the role of nutritional factors in the etiology of common diseases, such as cardiovascular and neoplastic diseases, has gradually emerged. Recent studies have been focused on examining the impact of a whole dietary approach rather than on isolating single nutrients; it is recognized that analyses of single nutrients ignore the important and complex interactions between components of a diet and, more importantly, because people do not eat isolated nutrients.
The optimal dietary strategy for the prevention of chronic degenerative diseases remains a challenging and a highly relevant preventive health issue. Over the last years, numerous evidence on the existing relationship between nutrition and chronic degenerative diseases have led investigators to search for the optimal dietary pattern to maintain a good health status. Several models of diet have been imposed on public attention, but those that got the most interest are certainly Mediterranean and vegetarian diets. These dietary patterns seem to exert protective effects on blood pressure, lipid profiles, cardiovascular diseases and metabolic parameters.
The term Mediterranean diet has been widely used to describe the traditional dietary habits of people in Crete, South Italy, and other Mediterranean countries during the decade of the 1960s. Since the first data from the Seven Countries Study, several studies in different populations have established a beneficial role for the main components of the Mediterranean diet on the occurrence of cardiovascular diseases and chronic degenerative diseases. This dietary pattern is characterized by plentiful plant foods (fruits, vegetables, breads, other forms of cereals, beans, nuts, and seeds), olive oil as the principal source of fat, moderate amounts of dairy products (mainly cheese and yogurt), low to moderate amounts of fish and poultry, red meat in low amounts and wine consumed in low to moderate quantities, usually with meals.
The vegetarian diet is a diet that excludes the use of animal foods (meat, fish) in its fresh, preserved and/or processed. The increase in the number of vegetarians is attributable to health, ethical, environmental, and social concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years
- •Willing and able to give informed consent
- •Presence of at least one of the following risk factors for cardiovascular disease (European Society of Cardiology guidelines on cardiovascular disease prevention):
- •BMI >o= 25 kg/m2
- •Waist circumference > 88 cm (women) or > 102 cm (men)
- •Circulating levels of total cholesterol > 190 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
- •Circulating levels of LDL cholesterol > 115 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
- •Levels of circulating triglycerides > 150 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
- •Circulating levels of fasting blood glucose > 110 and < 126 mg/dL, non-drug treatment (measured no more than 3 months prior to the start of the study)
- •Wiling to participate in a randomized study comparing two dietary profiles, one of which is a vegetarian dietary pattern
- •Successfully completed 3-day food diary
- •Wiling to be contacted at least twice during the study period to evaluate diet compliance
- •Wiling to provide blood and fecal samples
排除标准
- •Presence of current serious illness or unstable condition that requires physician supervision of diet or physical activity (e.g., recent myocardial infarction, chronic liver disease, inflammatory bowel diseases)
- •Pregnancy or intention to become pregnant in next 18 months
- •Current or recent (past 6 months) participation in weight loss treatment program or use of weight loss medication
- •Reporting no regular intake of meat, fish, or poultry for past month
结局指标
主要结局
Changes in Body Weight From Baseline
时间窗: baseline and 6 months
Changes in Body Weight From Baseline
次要结局
- Changes in Interleukin-17 From Baseline(baseline and 6 months)
- Changes in LDL Cholesterol From Baseline(baseline and 6 months)
- Changes in BMI From Baseline(baseline and 6 months)
- Changes in Total Cholesterol From Baseline(baseline and 6 months)
- Changes in Glucose From Baseline(baseline and 6 months)
- Changes in TBARS From Baseline(baseline and 6 months)
- Changes in Fat Mass From Baseline(baseline and 6 months)
- Changes in Triglycerides From Baseline(baseline and 6 months)
- Changes in L-derived ROS From Baseline(baseline and 6 months)
研究者
Francesco Sofi
Associate Professor of Clinical Nutrition
Azienda Ospedaliero-Universitaria Careggi
