Cardiovascular Disease
Conditions
Keywords
Plant extract, LDL cholesterol, Dietary supplement
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTCombination of Plant Extracts (BSL_EP025)
Each participant will consume 2 capsules daily at lunch for 8 weeks.
DIETARY_SUPPLEMENTPlacebo
Each participant will consume 2 capsules daily at lunch for 8 weeks.
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL cholesterol | 8 weeks | Levels of LDL cholesterol in plasma |
| Oxidized LDL cholesterol | 8 weeks | Levels of oxidized LDL cholesterol in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | 8 weeks | Levels of triglycerides in plasma |
| Glucose | 8 weeks | Levels of glucose in plasma |
| Blood pressure | 8 weeks | Systolic and diastolic blood pressure |
| Body mass index | 8 weeks | Weight/height ratio |
| Total cholesterol | 8 weeks | Levels of total cholesterol in plasma |
| ICAM-1 | 8 weeks | Plasma levels of ICAM-1 |
| Beta IL-1 | 8 weeks | Plasma levels of beta IL-1 |
| IL-6 | 8 weeks | Plasma levels of IL-6 |
| IL-10 | 8 weeks | Plasma levels of IL-10 |
| VCAM-1 | 8 weeks | Plasma levels of VCAM-1 |
| HDL cholesterol | 8 weeks | Levels of HDL cholesterol in plasma |
Countries
Spain
Outcome results
None listed