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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Combination of Plant Extracts (BSL_EP025)

• Registration Number: NCT04029727
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2019-05-24
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The volunteers will take two capsules daily with maltodextrin.
Combination of Plant Extracts (BSL_EP025)	Combination of Plant Extracts (BSL_EP025)	The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025)

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	8 weeks	Levels of LDL cholesterol in plasma
Oxidized LDL cholesterol	8 weeks	Levels of oxidized LDL cholesterol in plasma

Secondary Outcome Measures

Name	Time	Method
ICAM-1	8 weeks	Plasma levels of ICAM-1
IL-10	8 weeks	Plasma levels of IL-10
Total cholesterol	8 weeks	Levels of total cholesterol in plasma
HDL cholesterol	8 weeks	Levels of HDL cholesterol in plasma
Blood pressure	8 weeks	Systolic and diastolic blood pressure
Body mass index	8 weeks	Weight/height ratio
VCAM-1	8 weeks	Plasma levels of VCAM-1
Triglycerides	8 weeks	Levels of triglycerides in plasma
Glucose	8 weeks	Levels of glucose in plasma
Beta IL-1	8 weeks	Plasma levels of beta IL-1
IL-6	8 weeks	Plasma levels of IL-6

Trial Locations

Locations (1)

Biosearch Life; 🇪🇸 Granada, Andalucia, Spain