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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029727
• Other study ID #: C025
• Status: Completed
• Phase: N/A
• Start date: May 24, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Combination of Plant Extracts (BSL_EP025)
Each participant will consume 2 capsules daily at lunch for 8 weeks.
• Placebo
Each participant will consume 2 capsules daily at lunch for 8 weeks.

Locations

Country	Name	City	State
Spain	Biosearch Life	Granada	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	Levels of LDL cholesterol in plasma	8 weeks
Primary	Oxidized LDL cholesterol	Levels of oxidized LDL cholesterol in plasma	8 weeks
Secondary	Total cholesterol	Levels of total cholesterol in plasma	8 weeks
Secondary	HDL cholesterol	Levels of HDL cholesterol in plasma	8 weeks
Secondary	Triglycerides	Levels of triglycerides in plasma	8 weeks
Secondary	Glucose	Levels of glucose in plasma	8 weeks
Secondary	Blood pressure	Systolic and diastolic blood pressure	8 weeks
Secondary	Body mass index	Weight/height ratio	8 weeks
Secondary	VCAM-1	Plasma levels of VCAM-1	8 weeks
Secondary	ICAM-1	Plasma levels of ICAM-1	8 weeks
Secondary	Beta IL-1	Plasma levels of beta IL-1	8 weeks
Secondary	IL-6	Plasma levels of IL-6	8 weeks
Secondary	IL-10	Plasma levels of IL-10	8 weeks