Gut Microbiota as a Therapeutic Target for CVD (oliomicroFDG)

February 15, 2018 updated by: Fondazione Don Carlo Gnocchi Onlus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Controls
Other: High quality extra virgin olive oil
Cases and controls were given 40 g/die high quality extra virgin olive oil
ACTIVE_COMPARATOR: Cases
Other: High quality extra virgin olive oil
Cases and controls were given 40 g/die high quality extra virgin olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anti-inflammatory cytokines
Time Frame: Time 0 (T0)
Time 0 (T0)
changes in anti-inflammatory cytokines
Time Frame: after 3 months from T0 (T1)
after 3 months from T0 (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2014

Primary Completion (ACTUAL)

June 6, 2016

Study Completion (ACTUAL)

February 6, 2017

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (ACTUAL)

February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • olio1_FDG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on High quality extra virgin olive oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe