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临床试验/NCT03441802
NCT03441802已完成不适用

Gut Microbiota as a Novel Therapeutic Target for Prevention of Cardiovascular Diseases in Obese and Non-obese Adult Subjects

Fondazione Don Carlo Gnocchi Onlus0 个研究点目标入组 36 人开始时间: 2014年1月8日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: High quality extra virgin olive oil (Other)

Controls

Other

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

研究者

申办方类型
Other
责任方
Sponsor

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