Gut Microbiota as a Therapeutic Target for CVD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-08

Study Completion Date

2017-02-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cases

Group Type ACTIVE_COMPARATOR

High quality extra virgin olive oil

Intervention Type OTHER

Cases and controls were given 40 g/die high quality extra virgin olive oil

Controls

Group Type OTHER

High quality extra virgin olive oil

Intervention Type OTHER

Cases and controls were given 40 g/die high quality extra virgin olive oil

Interventions

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High quality extra virgin olive oil

Cases and controls were given 40 g/die high quality extra virgin olive oil

Intervention Type OTHER

Eligibility Criteria

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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.