Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03101436

Acronym

OLIWINE

Enrollment

Registered

2017-04-05

Start date

2015-02-02

Completion date

2015-05-06

Last updated

2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTExtra 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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Microbiota Changes	1 month	Changes in microbiome composition

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026