©2022 Stanford Medicine
Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients
Not Recruiting
Trial ID: NCT04030247
Purpose
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.
Official Title
Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients Participating in a Cardiovascular Disease Prevention Program
Stanford Investigator(s)
Rajesh Dash, MD PhD; Director of SSATHI & CardioClick
Associate Professor of Medicine (Cardiovascular Medicine)
Eligibility
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.
Intervention(s):
drug: Plant Sterol
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Rajesh Dash, MD, PhD
206-276-8976