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The objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
There is a strong relationship between serum cholesterol levels and cardiovascular diseases, especially between coronary artery disease and LDL-cholesterol (LDL).
LDL is the lipoprotein responsible for delivering cholesterol to cells. However, in recent years, special attention has been given to modified LDL, especially oxidized LDL, since it plays a very important role in the initiation and progression of the atheroma plaque.
There are environmental and genetic factors that can influence the type and levels of blood lipoproteins. Among the modulable factors (environmental) it has been observed that some phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due to their antioxidant and anti-inflammatory properties.
The objective of the present study is to evaluate the possible effect of the intake of a combination of plant extracts (BSL_EP025) on the levels of LDL-cholesterol and oxidized LDL-cholesterol in healthy individuals with LDL-cholesterol levels between 100 and 190 mg/dL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Plant Extracts (BSL_EP025) | Experimental | The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025) |
|
| Placebo | Placebo Comparator | The volunteers will take two capsules daily with maltodextrin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Plant Extracts (BSL_EP025) | Dietary Supplement | Each participant will consume 2 capsules daily at lunch for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | Levels of LDL cholesterol in plasma | 8 weeks |
| Oxidized LDL cholesterol | Levels of oxidized LDL cholesterol in plasma | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | Levels of total cholesterol in plasma | 8 weeks |
| HDL cholesterol | Levels of HDL cholesterol in plasma | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Quesada, MD, PhD | Medical specialist in Endocrinology, Hospital San Cecilio de Granada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biosearch Life | Granada | Andalusia | 18004 | Spain |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Placebo | Dietary Supplement | Each participant will consume 2 capsules daily at lunch for 8 weeks. |
|
| Triglycerides | Levels of triglycerides in plasma | 8 weeks |
| Glucose | Levels of glucose in plasma | 8 weeks |
| Blood pressure | Systolic and diastolic blood pressure | 8 weeks |
| Body mass index | Weight/height ratio | 8 weeks |
| VCAM-1 | Plasma levels of VCAM-1 | 8 weeks |
| ICAM-1 | Plasma levels of ICAM-1 | 8 weeks |
| Beta IL-1 | Plasma levels of beta IL-1 | 8 weeks |
| IL-6 | Plasma levels of IL-6 | 8 weeks |
| IL-10 | Plasma levels of IL-10 | 8 weeks |