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| Name | Class |
|---|---|
| Universidad Católica San Antonio de Murcia | OTHER |
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The aim of this randomized, parallel, two-arm, placebo-controlled, quadruple-blind clinical trial is to evaluate the efficacy of a polyphenol-enriched functional product in individuals with overweight or obesity, focusing primarily on body composition, insulin sensitivity, inflammatory markers, and other metabolic health parameters.
The duration of the study will be 60 days during which the investigational product or placebo will be consumed daily according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the polyphenol-enriched product or control product).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Daily consumption of the polyphenol-enriched functional product for 60 days. |
|
| Control | Placebo Comparator | Identically appearing placebo capsules consumed for 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyphenol-enriched functional product | Dietary Supplement | Polyphenol-enriched functional product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Evaluation of differences in body weight (kg) | Day 1 and Day 60 |
| Change in fat mass | Evaluation of differences in fat mass (kg) | Day 1 and Day 60 |
| Change in fat mass (%) | Evaluation of differences in fat mass percentage (%) | Day 1 and Day 60 |
| Change in Body Mass Index (BMI) | BMI will be calculated from measured weight and height using the formula weight (kg) / height² (m²). | Day 1 and Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting glucose | Assessment of changes in fasting glucose levels (mg/dL) | Day 1 and Day 60. |
| Change in fasting insulin | Assessment of changes in insulin levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Lucas Abellán | Universidad Católica San Antonio de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM San Antonio Catholic University of Murcia, Murcia, Murcia 30107 | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Control without active polyphenols | Dietary Supplement | Product with identical characteristics to the experimental product, but without active polyphenols. |
|
| Day 1 and Day 60. |
| Change in plasma leptin levels | Leptin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Change in plasma ghrelin levels | Ghrelin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL). | Day 1 and Day 60 |
| Change in plasma adiponectin levels | Adiponectin levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL). | Day 1 and Day 60 |
| Change in plasma SOCS3 levels | SOCS3 levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Change in plasma interleukin-1 (IL-1β) levels | Interleukin-1 (IL-1β) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Change in plasma interleukin-6 (IL-6) levels | Interleukin-6 (IL-6) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Change in plasma interleukin-10 (IL-10) levels | Interleukin-10 (IL-10) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Change in plasma oxidized LDL (oxLDL) levels | Oxidized LDL (oxLDL) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Change in plasma malondialdehyde (MDA) levels | Malondialdehyde (MDA) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (ng/mL). | Day 1 and Day 60 |
| Change in plasma superoxide dismutase (SOD) levels | superoxide dismutase (SOD) levels will be measured in fasting plasma samples using ELISA at baseline and after the intervention (pg/mL). | Day 1 and Day 60 |
| Changes in C-reactive protein (CRP) | Measurement of changes in C-reactive protein (mg/L) | Day 1 and Day 60 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |