Clinical trial NCT04029727: Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Plant extract
LDL cholesterol
Dietary supplement
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: LDL cholesterol
timeFrame: 8 weeks
measure: Oxidized LDL cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Total cholesterol
timeFrame: 8 weeks
measure: HDL cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: Glucose
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
measure: VCAM-1
timeFrame: 8 weeks
measure: ICAM-1
timeFrame: 8 weeks
measure: Beta IL-1
timeFrame: 8 weeks
measure: IL-6
timeFrame: 8 weeks
measure: IL-10
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Biosearch Life
state: Andalucia
Study officials:
affiliation: Medical specialist in Endocrinology, Hospital San Cecilio de Granada
name: Miguel Quesada, MD, PhD
role: STUDY_CHAIR
References: