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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029727
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Combination of Plant Extracts (BSL_EP025) Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : May 24, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029727


Locations
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Spain
Biosearch Life
Granada, Andalucia, Spain, 18004
Sponsors and Collaborators
Biosearch S.A.
Investigators
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Study Chair: Miguel Quesada, MD, PhD Medical specialist in Endocrinology, Hospital San Cecilio de Granada

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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT04029727     History of Changes
Other Study ID Numbers: C025
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosearch S.A.:
Plant extract
LDL cholesterol
Dietary supplement
Additional relevant MeSH terms:
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Cardiovascular Diseases