Gut Microbiota as a Therapeutic Target for CVD

NCT03441802 | Completed

• 1 other identifier: olio1_FDG
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• anti-inflammatory cytokines

  Time 0 (T0)

• changes in anti-inflammatory cytokines

  after 3 months from T0 (T1)

Study Arms (2)

Cases

ACTIVE COMPARATOR

Other: High quality extra virgin olive oil

Controls

OTHER

Other: High quality extra virgin olive oil

Interventions

High quality extra virgin olive oil OTHER

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

Cases; Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• eating disorders;
• recent or ongoing antibiotic therapy.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Related Publications (5)

• 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

  BACKGROUND

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

  BACKGROUND

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

  PMID: 27058556 BACKGROUND

• Boulange 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.

  PMID: 27098727 BACKGROUND

• Luisi MLE, Lucarini L, Biffi B, Rafanelli E, Pietramellara G, Durante M, Vidali S, Provensi G, Madiai S, Gheri CF, Masini E, Ceccherini MT. Effect of Mediterranean Diet Enriched in High Quality Extra Virgin Olive Oil on Oxidative Stress, Inflammation and Gut Microbiota in Obese and Normal Weight Adult Subjects. Front Pharmacol. 2019 Nov 15;10:1366. doi: 10.3389/fphar.2019.01366. eCollection 2019.

  PMID: 31803056 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 22, 2018
• Study Start: January 8, 2014
• Primary Completion: June 6, 2016
• Study Completion: February 6, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02