Skip to main content
OpenTrials
Completed

NCT Number: NCT03441802

Gut Microbiota as a Therapeutic Target for CVD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High quality extra virgin olive oil

Other

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

Primary outcomes

  1. anti-inflammatory cytokines

    Time frame: Time 0 (T0)

  2. changes in anti-inflammatory cytokines

    Time frame: after 3 months from T0 (T1)

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Acronym: oliomicroFDG

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 22, 2018
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.