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OpenTrials
Completed

NCT Number: NCT03101436

Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

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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Key information

Conditions

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

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Microbiota Changes

    Time frame: 1 month

    Changes in microbiome composition

Secondary outcomes

  1. Trimethylamine N-oxide (TMAO) production

    Time frame: 1 month

    Modifications in Trimethylamine N-oxide (TMAO) production

  2. Insulin Resistance

    Time frame: 1 Month

    Modifications in Insulin Resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR))

  3. Lipid Profile

    Time frame: 1 Month

    Changes in lipid profile (LDL, HDL, total cholesterol, triglycerides)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: OLIWINE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 5, 2017
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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