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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, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.
The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Consumption of dietary supplement capsules for 56 days. |
|
| Control Group | Placebo Comparator | Identically appearing placebo capsules consumed for 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phytosterol-rich extract | Dietary Supplement | Experimental product: extract rich in phytosterols |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipid profile | Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides | Day 1, at 28 and 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric parameters | Body weight (Kg), body mass index (kg/m^2) and waist circumference (cm) | Day 1, at 28 and 56 days |
| Body composition measures | Fat-free mass (Kg) and fat mass (Kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Desirée Victoria Montesinos | Universidad Católica San Antonio de Murcia | Principal Investigator |
| Ana Mª GarcÃa Muñoz | 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 | Spain |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D052439 | Lipid Metabolism Disorders |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Product with identical characteristics to the experimental product. |
|
| Day 1, at 28 and 56 days |
| Oxidation markers | Measurement of oxidized LDL | Day 1, at 28 and 56 days |
| Dietary Intake | Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ). | Day 1, at 28 and 56 days |
| Adherence to the Mediterranean diet | Measurement of adherence to the Mediterranean diet by the MEDAS questionnaire. | Day 1, at 28, and 56 days |
| Blood pressure | Systolic blood pressure and diastolic blood pressure (mmHg). | Day 1, at 28 and 56 days |
| Physical Activity | Measured by IPAQ/GPAQ questionnaire. | Day 1, at 28 and 56 days |
| Liver safety variables | It is a blood test that measures liver enzymes, such as GPT (ALT) and GOT (AST), to evaluate liver function. | Day 1, at 28 and 56 days |