Phase 4
N=50
Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients
Cardiovascular Risk Factor
Bottom Line
View on ClinicalTrials.gov: NCT04030247 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: LDL-C at Month 3 — 145 mg/dL — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Plant Sterol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDL-C at Month 3 |
145 | 0.03 sig |
| SECONDARY Total Cholesterol at Month 3 |
216 | 0.16 |
| SECONDARY Calculated LDL-C at Month 3 |
145 | 0.03 sig |
| SECONDARY HDL-C at Month 3 |
50 | 0.9 |
| SECONDARY Triglycerides at Month 3 |
142 | 0.5 |
| SECONDARY Fasting Glucose at Month 3 |
96 | 0.4 |
| SECONDARY Fasting Insulin at Month 3 |
10.2 | — |
| SECONDARY HbA1c at Month 3 |
5.5 | 0.6 |
| SECONDARY Percent Change in Non-HDL-C From Baseline to 3 Months |
— | — |
| SECONDARY Percent Change in Lp(a) From Baseline to 3 Months |
— | — |
| SECONDARY Percent Change in Apoprotein B-100 From Baseline to 3 Months |
— | — |
| SECONDARY Percent Change in Apoprotein A1 From Baseline to 3 Months |
— | — |
| SECONDARY Percent Change in Ratio, ApoB-100/Apo A1 From Baseline to 3 Months |
— | — |
| SECONDARY Percent Change in C-reactive Protein From Baseline to 3 Months |
— | — |
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
- Subject is a South Asian male or female, ≥18 years of age
- Subject has LDL-C ≥120 and 7.5% who are known to be intolerant of statin therapy drugs.
- Subjects with LDL-C > 189 mg/dl or ASCVD > 7.5% who have declined prescription medical therapy.
- If current smoker, subject does not have any plans to change current smoking status or frequency.
- Subject is willing to fast (10-14 h, target 12 h, water only) prior to each clinic visit.
- 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.
- Subject is agreeable to receiving clinical care virtually.
Exclusion Criteria
- Subject has taken a prescription cholesterol-lowering medication in the past 1 month.
- Subject has a known allergy or sensitivity to soy, corn, or other ingredients in the study product.
- 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.)
- 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.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04030247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.