Gut Microbiota as a Therapeutic Target for CVD
- Conditions
- Obesity
- Interventions
- Other: High quality extra virgin olive oil
- Registration Number
- NCT03441802
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- eating disorders;
- recent or ongoing antibiotic therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cases High quality extra virgin olive oil - Controls High quality extra virgin olive oil -
- Primary Outcome Measures
Name Time Method changes in anti-inflammatory cytokines after 3 months from T0 (T1) anti-inflammatory cytokines Time 0 (T0)
- Secondary Outcome Measures
Name Time Method