Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

Study Overview
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Brief Summary
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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.

Official Title
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Extra Virgin Olive Oil and Red Wine Polyphenols in the Modulation of Fecal Microbiota: an Interventional Study

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Extra Virgin Olive Oil and Red Wine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lean Subjects<br>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) | Dietary Supplement: Extra Virgin Olive Oil and Red Wine<br>* Phase I: Extra VIrgin Olive Oil 80 grams per day (1 month) Washout Period: 15 days Phase II: Red Wine (270 ml per day) (1 month)<br>|
| Experimental: Obese Subjects<br>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) | Dietary Supplement: Extra Virgin Olive Oil and Red Wine<br>* Phase I: Extra VIrgin Olive Oil 80 grams per day (1 month) Washout Period: 15 days Phase II: Red Wine (270 ml per day) (1 month)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota Changes | Changes in microbiome composition | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Resistance, Extra Virgin Olive Oil, Red Wine, Diet, Microbiota