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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Biosearch S.A.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- LDL cholesterol
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
LDL cholesterol
Time Frame: 8 weeks
Levels of LDL cholesterol in plasma
Oxidized LDL cholesterol
Time Frame: 8 weeks
Levels of oxidized LDL cholesterol in plasma
Secondary Outcomes
- Triglycerides(8 weeks)
- Glucose(8 weeks)
- Beta IL-1(8 weeks)
- IL-6(8 weeks)
- ICAM-1(8 weeks)
- IL-10(8 weeks)
- Total cholesterol(8 weeks)
- HDL cholesterol(8 weeks)
- Blood pressure(8 weeks)
- Body mass index(8 weeks)
- VCAM-1(8 weeks)