Trial Search Results
The Effects of Plant Sterol Supplementation on LDL Levels in Intermediate Cardiovascular Risk Individuals
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.
Stanford is currently not accepting patients for this trial.
Collaborator: Piper Biosciences, Inc.
- Drug: Plant Sterol
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
5. Subject is willing to fast (10-14 h, target 12 h, water only) prior to each clinic
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.
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
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
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.
Ages Eligible for Study
18 Years - 60 Years
Genders Eligible for Study