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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Combination of Plant Extracts (BSL_EP025); Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18004
      • Biosearch Life

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of Plant Extracts (BSL_EP025); The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025)	Dietary supplement: Combination of Plant Extracts (BSL_EP025); Each participant will consume 2 capsules daily at lunch for 8 weeks.
Placebo Comparator: Placebo; The volunteers will take two capsules daily with maltodextrin.	Dietary supplement: Placebo; Each participant will consume 2 capsules daily at lunch for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL cholesterol	Levels of LDL cholesterol in plasma	8 weeks
Oxidized LDL cholesterol	Levels of oxidized LDL cholesterol in plasma	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Study Chair: Miguel Quesada, MD, PhD, Medical specialist in Endocrinology, Hospital San Cecilio de Granada

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Dietary supplement; LDL cholesterol; Plant extract
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: C025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No