Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study to Evaluate the Effect of the Consumption of a Combination of Plant Extracts (BSL_EP025) on the Levels of LDL-cholesterol and Oxidized LDL-cholesterol in Healthy Volunteers

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Combination of Plant Extracts (BSL_EP025)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women between 18 and 65 years of age. Levels of LDL-cholesterol between 100 and 190 mg/dL. Accept freely to participate in the study and sign the informed consent document. Exclusion Criteria: Be pregnant. Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks. Suffer from a serious illness. Have diabetes. Having a cerebrovascular disease. Be taking products or drugs to control cholesterol levels or with antioxidant activity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of Plant Extracts (BSL_EP025)<br>The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025) | Dietary Supplement: Combination of Plant Extracts (BSL_EP025)<br>* Each participant will consume 2 capsules daily at lunch for 8 weeks.<br>|
| Placebo Comparator: Placebo<br>The volunteers will take two capsules daily with maltodextrin. | Dietary Supplement: Placebo<br>* Each participant will consume 2 capsules daily at lunch for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Levels of total cholesterol in plasma | 8 weeks | 
| HDL cholesterol | Levels of HDL cholesterol in plasma | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant extract, LDL cholesterol, Dietary supplement