Gut Microbiota as a Therapeutic Target for CVD

Obesity Clinical Trial

— oliomicroFDG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441802
• Other study ID #: olio1_FDG
• Status: Completed
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 15, 2018
• Start date: January 8, 2014
• Est. completion date: February 6, 2017

Study information

• Verified date: February 2018
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 6, 2017
• Est. primary completion date: June 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• High quality extra virgin olive oil
Cases and controls were given 40 g/die high quality extra virgin olive oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

References & Publications (4)

1) Oliveras-López M-J, Berná G, Jurado-Ruiz E, López-García de la Serrana H, Martín F. Consumption of extra-virgin olive oil rich in phenolic compounds has beneficial antioxidant effects in healthy human adults. J Funct Foods 2014;10:475-84

2) Hervert-Hernández D, Goñi I. Dietary Polyphenols and Human Gut Microbiota: a Review. Food Reviews International. 2011;27:154-69.

Boulangé CL, Neves AL, Chilloux J, Nicholson JK, Dumas ME. Impact of the gut microbiota on inflammation, obesity, and metabolic disease. Genome Med. 2016 Apr 20;8(1):42. doi: 10.1186/s13073-016-0303-2. Review. — View Citation

Woting A, Blaut M. The Intestinal Microbiota in Metabolic Disease. Nutrients. 2016 Apr 6;8(4):202. doi: 10.3390/nu8040202. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-inflammatory cytokines		Time 0 (T0)
Primary	changes in anti-inflammatory cytokines		after 3 months from T0 (T1)