Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients

Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients Participating in a Cardiovascular Disease Prevention Program

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Drug: Plant Sterol

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 low-to-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. In addition, patients who may qualify for statin therapy, but are deemed to be intolerant of statins or who refuse lipid lowering medication may also qualify.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is a South Asian male or female, ≥18 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 or cholesterol-lowering supplement 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. Subjects with LDL-C > 189 mg/dl or ASCVD > 7.5% who have declined prescription medical therapy.
5. If current smoker, subject does not have any plans to change current smoking status or frequency.
6. Subject is willing to fast (10-14 h, target 12 h, water only) prior to each clinic visit.
7. 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.
8. Subject is agreeable to receiving clinical care virtually.

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, corn, or other 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Plant Sterol; South Asian participants 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 from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL-C at Month 3	month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol at Month 3		month 3
Calculated LDL-C at Month 3		month 3
HDL-C at Month 3		month 3
Triglycerides at Month 3		month 3
Fasting Glucose at Month 3		month 3
Fasting Insulin at Month 3		month 3
HbA1c at Month 3		month 3
Percent Change in Non-HDL-C From Baseline to 3 Months	% change in baseline measurement non-HDL-C to 3 months	Baseline, 3 months
Percent Change in Lp(a) From Baseline to 3 Months	% change in baseline measurement Lp(a) to 3 months	Baseline, 3 months
Percent Change in Apoprotein B-100 From Baseline to 3 Months	% change in baseline measurement Apoprotein B-100 to 3 months	Baseline, 3 months
Percent Change in Apoprotein A1 From Baseline to 3 Months	% change in baseline measurement Apoprotein A1 to 3 months	Baseline, 3 months
Percent Change in Ratio, ApoB-100/Apo A1 From Baseline to 3 Months	% change in baseline measurement ratio, ApoB-100/Apo A1 to 3 months	Baseline, 3 months
Percent Change in C-reactive Protein From Baseline to 3 Months	% change in baseline measurement in C-reactive protein to 3 months	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Piper Biosciences, Inc.
• Investigators: Study Director: Gerri O'Riordan, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 51046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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