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The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double blind, placebo controlled study of 12 weeks will be carried out.
The target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Capsules containing placebo. |
|
| Polyhpenol extract | Experimental | Capsules containing the experimental polyhpenol to be assayed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyhpenol extract | Dietary Supplement | Three capsules in fasting conditions 15 minutes prior breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | Serum concentration of Total Cholesterol | Baseline |
| Total cholesterol | Serum concentration of Total Cholesterol | 12 weeks |
| HDL cholesterol | Serum concentration of HDL cholesterol | Baseline |
| HDL cholesterol | Serum concentration of HDL cholesterol | 12 weeks |
| LDL cholesterol | Serum Calculated LDL Cholesterol levels | Baseline |
| LDL cholesterol | Serum Calculated LDL Cholesterol levels | 12 weeks |
| Triglycerides | Serum Triglycerides levels | Baseline |
| Triglycerides | Serum Triglycerides levels | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight status | Baseline |
| Weight | Weight status | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigacion en Nutricion. Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Parallel groups double blind, 12-week nutritional intervention
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| Placebo | Dietary Supplement | Three capsules in fasting conditions 15 minutes before breakfast |
|
| Fat mass |
Fat mass in kg, measured by Bioimpedance |
| Baseline |
| Fat mass | Fat mass in kg, measured by Bioimpedance | 12 weeks |
| Hemoglobin | Hemoglobin measured as mg/dL | Baseline |
| Hemoglobin | Hemoglobin measured as mg/dL | 12 weeks |
| Hematocrit | Hematocrit (%) | Baseline |
| Hematocrit | Hematocrit (%) | 12 weeks |
| Physical Activity | Measured through the IPAQ questionnaire | Baseline |
| Physical Activity | Measured through the IPAQ questionnaire | 12 weeks |
| Blood pressure | Measured in the dominant arm (mmHg) | Baseline |
| Blood pressure | Measured in the dominant arm (mmHg) | 12 weeks |
| Dietary intake | FFQ from the SUN Study | Baseline |
| Dietary intake | FFQ from the SUN Study | 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |