Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Piper Biosciences, Inc.

Intervention(s):

  • Drug: Plant Sterol

Phase:

Phase 4

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rajesh Dash, MD, PhD
206-276-8976