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Completed

NCT Number: NCT04029727

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biosearch Life

Granada, Andalusia, 18004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination of Plant Extracts (BSL_EP025)

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. LDL cholesterol

    Time frame: 8 weeks

    Levels of LDL cholesterol in plasma

  2. Oxidized LDL cholesterol

    Time frame: 8 weeks

    Levels of oxidized LDL cholesterol in plasma

Secondary outcomes

  1. Total cholesterol

    Time frame: 8 weeks

    Levels of total cholesterol in plasma

  2. HDL cholesterol

    Time frame: 8 weeks

    Levels of HDL cholesterol in plasma

  3. Triglycerides

    Time frame: 8 weeks

    Levels of triglycerides in plasma

  4. Glucose

    Time frame: 8 weeks

    Levels of glucose in plasma

  5. Blood pressure

    Time frame: 8 weeks

    Systolic and diastolic blood pressure

  6. Body mass index

    Time frame: 8 weeks

    Weight/height ratio

  7. VCAM-1

    Time frame: 8 weeks

    Plasma levels of VCAM-1

  8. ICAM-1

    Time frame: 8 weeks

    Plasma levels of ICAM-1

  9. Beta IL-1

    Time frame: 8 weeks

    Plasma levels of beta IL-1

  10. IL-6

    Time frame: 8 weeks

    Plasma levels of IL-6

  11. IL-10

    Time frame: 8 weeks

    Plasma levels of IL-10

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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