Gut Microbiota as a Novel Therapeutic Target for Prevention of Cardiovascular Diseases in Obese and Non-obese Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- changes in anti-inflammatory cytokines
研究概览
简要总结
Background: The Mediterranean Diet (MD) is considered an healthy diet useful in the prevention of cardiovascular disease (CVD). High quality extra virgin olive oil (HQ-EVOO, [1]), an essential component of this diet, exerts a protective effect against CVD. Moreover, the gut microbiota (GM) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity [2]. In particular, Lactic Acid Bacteria (LAB) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and CVD [3,4].
Objective: The purpose of this study is to demonstrate that 3 months of treatment (MD with 40g/die HQ-EVOO) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their GM and inflammatory panel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal weight subjects (M and F) with Body Mass Index (BMI) between 18.5 and 24.9 Kg/m2 following MD;
- •overweight/obese subjects with a BMI ≥ 25 Kg/m2, not necessarily following MD.
排除标准
- •eating disorders;
- •recent or ongoing antibiotic therapy.
研究组 & 干预措施
Cases
干预措施: High quality extra virgin olive oil (Other)
Controls
干预措施: High quality extra virgin olive oil (Other)
结局指标
主要结局
changes in anti-inflammatory cytokines
时间窗: after 3 months from T0 (T1)
anti-inflammatory cytokines
时间窗: Time 0 (T0)
次要结局
未报告次要终点
