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

April 4, 2017 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Dietary supplement: 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)
Experimental: 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)
Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Instituto de Salud Carlos III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2015

Primary Completion (Actual)

May 6, 2015

Study Completion (Actual)

May 6, 2015

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JCMI2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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