Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

NCT03101436 | Completed

• 1 other identifier: JCMI2017
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Insulin Resistance; Extra Virgin Olive Oil; Red Wine; Diet; Microbiota

Outcome Measures

Primary Outcomes (1)

• Microbiota Changes

  Changes in microbiome composition

  1 month

Secondary Outcomes (3)

• Trimethylamine N-oxide (TMAO) production

  1 month

• Insulin Resistance

  1 Month

• Lipid Profile

  1 Month

Study Arms (2)

Lean Subjects

EXPERIMENTAL

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

Obese Subjects

EXPERIMENTAL

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

Interventions

Extra Virgin Olive Oil and Red Wine 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)

Lean Subjects; Obese Subjects

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 5, 2017
• Study Start: February 2, 2015
• Primary Completion: May 6, 2015
• Study Completion: May 6, 2015
• Last Updated: April 5, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share