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出境医 / 临床实验 / The Effects of Plant Sterol Supplementation on LDL Levels in Intermediate Cardiovascular Risk Individuals

The Effects of Plant Sterol Supplementation on LDL Levels in Intermediate Cardiovascular Risk Individuals

Study Description
Brief Summary:
The purpose of this study is to measure the incremental effectiveness of a twice daily plant sterol supplement in a population of young South Asian patients who have moderate cardiovascular disease (CVD) risk.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Drug: Plant Sterol Phase 4

Detailed Description:
In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation added to a proven CVD reduction program for moderate risk South Asians who do not meet guideline-based criteria (2018 ACC/AHA Lipid Guidelines) for medical lowering of their LDL-C with an HMG CoA reductase inhibitor (statin) drug, and they are recommended to improve their lipid-risk profile through diet and exercise primarily.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Plant Sterol Supplementation on LDL Levels in Intermediate Cardiovascular Risk Individuals
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Plant Sterol
A randomized group of South Asians with moderate cardiovascular disease risk will receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
 Drug: Plant Sterol
Patients will receive a plant sterol supplement to take twice daily in addition to the standard of care from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
Other Name: Standard of Care in management of Cardiovascular Risk Factor
No Intervention: Control
A randomized group of South Asians with moderate cardiovascular disease risk will receive standard of care.
Outcome Measures
Primary Outcome Measures :
  1. Percent change in LDL-C from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement of LDL-C to 3 months LDL-C


Secondary Outcome Measures :
  1. Percent change in total cholesterol from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement of total cholesterol to 3 months

  2. Percent change in calculated LDL-C from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement of calculated LDL-C to 3 months

  3. Percent change in HDL from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement HDL to 3 months

  4. Percent change in non-HDL-C from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement non-HDL-C to 3 months

  5. Percent change in triglycerides from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement triglycerides to 3 months

  6. Percent change in Lp(a) from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement Lp(a) to 3 months

  7. Percent change in Apoprotein B-100 from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement Apoprotein B-100 to 3 months

  8. Percent change in Apoprotein A1 from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement Apoprotein A1 to 3 months

  9. Percent change in Ratio, ApoB-100/Apo A1 from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement ratio, ApoB-100/Apo A1 to 3 months

  10. Percent change in C-reactive protein from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement in C-reactive protein to 3 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is a male or female, ≥18 years of age, < 61 years of age.
  2. Subject has LDL-C ≥120 and <190 mg/dL measured in the past 3 months (or measured at the baseline visit), while not taking cholesterol-lowering medication for at least 1 month prior, and having a ASCVD Risk score <7.5%.
  3. Subjects with LDL-C ≥120 and <190 mg/dL with ASCVD risk scores >7.5% who are known to be intolerant of statin therapy drugs.
  4. If current smoker, subject does not have any plans to change current smoking status or frequency.
  5. Subject is willing to fast (10-14 h, target 12 h, water only) prior to each clinic visit.
  6. Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
  7. Subject is agreeable to virtual CardioClick follow up visits from MD as well as dietitian/health coach and consents to virtual clinical care pathway.

Exclusion Criteria:

  1. Subject has taken a prescription cholesterol-lowering medication in the past 1 month.
  2. Subject has a known allergy or sensitivity to soy or any ingredients in the study product.

  3. Subject is taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin >100 mg/d or omega-3 fatty acid supplements providing ≥1000 mg/d eicosapentaenoic acid and/or docosahexaenoic acid.

    (Stable use of viscous fiber laxative ≤2 teaspoons/d is allowed.)

  4. Subject is a female, who is pregnant, planning to be pregnant during the study period, or lactating. Subjects should agree to use contraception during study period to avoid pregnancy.
  5. Individual has active angina, stable or unstable, requiring urgent cardiovascular functional risk stratification (stress testing or catheterization) or intervention. Or has congestive heart failure that is not compensated or in which the subject is not euvolemic, as determined by the treating MD.
  6. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Rajesh Dash, MD, PhD 206-276-8976 rhombus@stanford.edu
Contact: Kathleen Gallagher kgallagh@stanford.edu

Sponsors and Collaborators
Stanford University
Piper Biosciences, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Rajesh Dash, MD, PhD Stanford University
Study Director: Gerri O'Riordan Stanford University
Tracking Information
First Submitted Date  ICMJE July 19, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019) 		Percent change in LDL-C from baseline to 3 months [ Time Frame: Baseline, 3 months ]
% change in baseline measurement of LDL-C to 3 months LDL-C
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Percent change in total cholesterol from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement of total cholesterol to 3 months
  • Percent change in calculated LDL-C from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement of calculated LDL-C to 3 months
  • Percent change in HDL from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement HDL to 3 months
  • Percent change in non-HDL-C from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement non-HDL-C to 3 months
  • Percent change in triglycerides from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement triglycerides to 3 months
  • Percent change in Lp(a) from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement Lp(a) to 3 months
  • Percent change in Apoprotein B-100 from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement Apoprotein B-100 to 3 months
  • Percent change in Apoprotein A1 from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement Apoprotein A1 to 3 months
  • Percent change in Ratio, ApoB-100/Apo A1 from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement ratio, ApoB-100/Apo A1 to 3 months
  • Percent change in C-reactive protein from baseline to 3 months [ Time Frame: Baseline, 3 months ]
    % change in baseline measurement in C-reactive protein to 3 months
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 The Effects of Plant Sterol Supplementation on LDL Levels in Intermediate Cardiovascular Risk Individuals
Official Title  ICMJE The Effects of Plant Sterol Supplementation on LDL Levels in Intermediate Cardiovascular Risk Individuals
Brief Summary The purpose of this study is to measure the incremental effectiveness of a twice daily plant sterol supplement in a population of young South Asian patients who have moderate cardiovascular disease (CVD) risk.
Detailed Description In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation added to a proven CVD reduction program for moderate risk South Asians who do not meet guideline-based criteria (2018 ACC/AHA Lipid Guidelines) for medical lowering of their LDL-C with an HMG CoA reductase inhibitor (statin) drug, and they are recommended to improve their lipid-risk profile through diet and exercise primarily.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Risk Factor
Intervention  ICMJE Drug: Plant Sterol
Patients will receive a plant sterol supplement to take twice daily in addition to the standard of care from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
Other Name: Standard of Care in management of Cardiovascular Risk Factor
Study Arms  ICMJE
  • Experimental: Plant Sterol
    A randomized group of South Asians with moderate cardiovascular disease risk will receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months.
    Intervention: Drug: Plant Sterol
  • No Intervention: Control
    A randomized group of South Asians with moderate cardiovascular disease risk will receive standard of care.
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is a male or female, ≥18 years of age, < 61 years of age.
  2. Subject has LDL-C ≥120 and <190 mg/dL measured in the past 3 months (or measured at the baseline visit), while not taking cholesterol-lowering medication for at least 1 month prior, and having a ASCVD Risk score <7.5%.
  3. Subjects with LDL-C ≥120 and <190 mg/dL with ASCVD risk scores >7.5% who are known to be intolerant of statin therapy drugs.
  4. If current smoker, subject does not have any plans to change current smoking status or frequency.
  5. Subject is willing to fast (10-14 h, target 12 h, water only) prior to each clinic visit.
  6. Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
  7. Subject is agreeable to virtual CardioClick follow up visits from MD as well as dietitian/health coach and consents to virtual clinical care pathway.

Exclusion Criteria:

  1. Subject has taken a prescription cholesterol-lowering medication in the past 1 month.
  2. Subject has a known allergy or sensitivity to soy or any ingredients in the study product.

  3. Subject is taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin >100 mg/d or omega-3 fatty acid supplements providing ≥1000 mg/d eicosapentaenoic acid and/or docosahexaenoic acid.

    (Stable use of viscous fiber laxative ≤2 teaspoons/d is allowed.)

  4. Subject is a female, who is pregnant, planning to be pregnant during the study period, or lactating. Subjects should agree to use contraception during study period to avoid pregnancy.
  5. Individual has active angina, stable or unstable, requiring urgent cardiovascular functional risk stratification (stress testing or catheterization) or intervention. Or has congestive heart failure that is not compensated or in which the subject is not euvolemic, as determined by the treating MD.
  6. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rajesh Dash, MD, PhD 206-276-8976 rhombus@stanford.edu
Contact: Kathleen Gallagher kgallagh@stanford.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04030247
Other Study ID Numbers  ICMJE 51046
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rajesh Dash, MD PHD, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Piper Biosciences, Inc.
Investigators  ICMJE
Principal Investigator: Rajesh Dash, MD, PhD Stanford University
Study Director: Gerri O'Riordan Stanford University
PRS Account Stanford University
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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