Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health
NCT ID: NCT04029727
Last Updated: 2019-11-15
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-05-24
2019-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
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)
Combination of Plant Extracts (BSL_EP025)
Each participant will consume 2 capsules daily at lunch for 8 weeks.
Placebo
The volunteers will take two capsules daily with maltodextrin.
Placebo
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.
Placebo
Each participant will consume 2 capsules daily at lunch for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Biosearch S.A.
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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C025
Identifier Type: -
Identifier Source: org_study_id
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