Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota (OLIWINE)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Extra Virgin Olive Oil and Red Wine

Study type: Interventional

Funder types: Other

Identifiers

NCT03101436

JCMI2017

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Lean Subjects

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Extra Virgin Olive Oil and Red Wine

Obese Subjects

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Extra Virgin Olive Oil and Red Wine