Gut Microbiota as a Therapeutic Target for CVD (oliomicroFDG)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Obesity

Treatments: Other: High quality extra virgin olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03441802

olio1_FDG

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• eating disorders;
• recent or ongoing antibiotic therapy.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Cases

Active Comparator group

Treatment:

Other: High quality extra virgin olive oil

Controls

Other group

Treatment:

Other: High quality extra virgin olive oil