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出境医 / 临床实验 / Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health

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

Study Description
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.

Study Design
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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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

Locations
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Spain
Biosearch Life
Granada, Andalucia, Spain, 18004
Sponsors and Collaborators
Biosearch S.A.
Investigators
Layout table for investigator information
Study Chair: Miguel Quesada, MD, PhD Medical specialist in Endocrinology, Hospital San Cecilio de Granada
Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE May 24, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • LDL cholesterol [ Time Frame: 8 weeks ]
    Levels of LDL cholesterol in plasma
  • Oxidized LDL cholesterol [ Time Frame: 8 weeks ]
    Levels of oxidized LDL cholesterol in plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Total cholesterol [ Time Frame: 8 weeks ]
    Levels of total cholesterol in plasma
  • HDL cholesterol [ Time Frame: 8 weeks ]
    Levels of HDL cholesterol in plasma
  • Triglycerides [ Time Frame: 8 weeks ]
    Levels of triglycerides in plasma
  • Glucose [ Time Frame: 8 weeks ]
    Levels of glucose in plasma
  • Blood pressure [ Time Frame: 8 weeks ]
    Systolic and diastolic blood pressure
  • Body mass index [ Time Frame: 8 weeks ]
    Weight/height ratio
  • VCAM-1 [ Time Frame: 8 weeks ]
    Plasma levels of VCAM-1
  • ICAM-1 [ Time Frame: 8 weeks ]
    Plasma levels of ICAM-1
  • Beta IL-1 [ Time Frame: 8 weeks ]
    Plasma levels of beta IL-1
  • IL-6 [ Time Frame: 8 weeks ]
    Plasma levels of IL-6
  • IL-10 [ Time Frame: 8 weeks ]
    Plasma levels of IL-10
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • Dietary Supplement: Combination of Plant Extracts (BSL_EP025)
    Each participant will consume 2 capsules daily at lunch for 8 weeks.
  • Dietary Supplement: Placebo
    Each participant will consume 2 capsules daily at lunch for 8 weeks.
Study Arms  ICMJE
  • Experimental: Combination of Plant Extracts (BSL_EP025)
    The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP025)
    Intervention: Dietary Supplement: Combination of Plant Extracts (BSL_EP025)
  • Placebo Comparator: Placebo
    The volunteers will take two capsules daily with maltodextrin.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04029727
Other Study ID Numbers  ICMJE C025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biosearch S.A.
Study Sponsor  ICMJE Biosearch S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Miguel Quesada, MD, PhD Medical specialist in Endocrinology, Hospital San Cecilio de Granada
PRS Account Biosearch S.A.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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