Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Extra Virgin Olive Oil and Red Wine

• Registration Number: NCT03101436
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-02
• Primary Completion: 2015-05-06
• Study Completion: 2015-05-06
• Status Verified: 2017-03
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-05
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Obese patients (body mass index (BMI= or > 30kg/m2) with high insulin resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) > 5.5.
• Lean subjects (BMI< 28kg/m2) with low insulin resistance (HOMA-IR< 3.3).

Exclusion Criteria (all patients):

• Type 2 diabetes
• Acute or chronic infection
• Inflammatory disease or endocrine disorders.
• History of cancer.
• Anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment
• A history of alcohol abuse or drug dependence
• A restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
• Intake of prebiotics, probiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lean Subjects	Extra Virgin Olive Oil and Red Wine	Part 1: Mediterranean diet with added extra virgin olive oil (80 gr per day) (1 month) Washout 15 days Part 2: Mediterranean diet with added Red Wine (270 ml per day) (1 month)
Obese Subjects	Extra Virgin Olive Oil and Red Wine	Part 1: Mediterranean diet with added extra virgin olive oil (80 gr per day) (1 month) Washout 15 days Part 2: Mediterranean diet with added Red Wine (270 ml per day) (1 month)

Primary Outcome Measures

Name	Time	Method
Microbiota Changes	1 month	Changes in microbiome composition

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance	1 Month	Modifications in Insulin Resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR))
Trimethylamine N-oxide (TMAO) production	1 month	Modifications in Trimethylamine N-oxide (TMAO) production
Lipid Profile	1 Month	Changes in lipid profile (LDL, HDL, total cholesterol, triglycerides)