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| Name | Class |
|---|---|
| Hospital General Universitario Reina SofÃa de Murcia | OTHER |
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The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate extract-1 | Experimental | Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks |
|
| Placebo-1 | Placebo Comparator | Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks |
|
| Placebo-2 | Placebo Comparator | Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out |
|
| Pomegranate extract-2 | Experimental | Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate extract | Dietary Supplement | Pomegranate extract consumption (900 mg/day) for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change (1 log units) of Bacteroidetes per gram of feces | Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio) | Change from baseline at 30 days vs placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP) | Evaluation of metabolic endotoxemia | Changes from baseline at 30 days vs placebo |
| Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan C EspÃn, PhD | Spanish National Research Council (CSIC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spanish National Research Council (CSIC) | Murcia | 30100 | Spain |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000712310 | pomegranate fruit rind |
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Randomized, double-blind, placebo-controlled and crossover trial.
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| Placebo | Other | Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks |
|
Determination of metabolic and inflammatory markers in serum samples. |
| Changes from baseline at 30 days vs placebo |
| Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL). | Determination of fibrinolytic, inflammatory and metabolic markers in serum samples | Changes from baseline at 30 days vs placebo |
| Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL) | Measurement of cell adhesion molecules in serum samples | Changes from baseline at 30 days vs placebo |
| Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL) | Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples | Changes from baseline at 30 days vs placebo |
| Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases | SNP genotyping of patients (DNA extracted from whole blood) | Baseline values at inclusion |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |