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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota Changes | Changes in microbiome composition | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Trimethylamine N-oxide (TMAO) production | Modifications in Trimethylamine N-oxide (TMAO) production | 1 month |
| Insulin Resistance | Modifications in Insulin Resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)) |
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Inclusion Criteria:
Exclusion Criteria (all patients):
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Phase I: Intervention with Diet (Extra Virgin Olive Oil) Washout Period Phase I: Intervention with Diet (Red Wine)
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| 1 Month |
| Lipid Profile | Changes in lipid profile (LDL, HDL, total cholesterol, triglycerides) | 1 Month |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |