Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-02

Study Completion Date

2015-05-06

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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lean Subjects

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)

Group Type EXPERIMENTAL

Extra Virgin Olive Oil and Red Wine

Intervention Type DIETARY_SUPPLEMENT

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)

Obese Subjects

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)

Group Type EXPERIMENTAL

Extra Virgin Olive Oil and Red Wine

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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Extra Virgin Olive Oil and Red Wine

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)

Intervention Type DIETARY_SUPPLEMENT

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

* 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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes