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Gut Microbiota as a Therapeutic Target for CVD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03441802
Acronym
oliomicroFDG
Enrollment
36
Registered
2018-02-22
Start date
2014-01-08
Completion date
2017-02-06
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

OTHERHigh quality extra virgin olive oil

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

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
anti-inflammatory cytokinesTime 0 (T0)
changes in anti-inflammatory cytokinesafter 3 months from T0 (T1)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026