Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients
Condition: Cardiovascular Risk Factor
Intervention: Plant Sterol
Intervention description: Patients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.