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

NCT ID: NCT04029727

Last Updated: 2019-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-24

Study Completion Date

2019-07-31

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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Combination of Plant Extracts (BSL_EP025)

The volunteers will take two capsules daily with a combination of plant extracts (BSL\_EP025)

Group Type EXPERIMENTAL

Combination of Plant Extracts (BSL_EP025)

Intervention Type DIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Placebo

The volunteers will take two capsules daily with maltodextrin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Interventions

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Combination of Plant Extracts (BSL_EP025)

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biosearch S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel Quesada, MD, PhD

Role: STUDY_CHAIR

Medical specialist in Endocrinology, Hospital San Cecilio de Granada

Locations

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Biosearch Life

Granada, Andalusia, Spain

Site Status

Countries

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Spain

Other Identifiers

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C025

Identifier Type: -

Identifier Source: org_study_id

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