Clinical trial NCT04030247: Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Risk Factor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Piper Biosciences, Inc.
First posted: 2019-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation added to a proven CVD reduction program for low-to-moderate risk South Asians who do not meet guideline-based criteria (2018 ACC/AHA Lipid Guidelines) for medical lowering of their LDL-C with an HMG CoA reductase inhibitor (statin) drug, and they are recommended to improve their lipid-risk profile through diet and exercise primarily. In addition, patients who may qualify for statin therapy, but are deemed to be intolerant of statins or who refuse lipid lowering medication may also qualify.

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.

Primary outcomes:
measure: LDL-C at Month 3
timeFrame: month 3
Secondary outcomes:
measure: Total Cholesterol at Month 3
timeFrame: month 3
measure: Calculated LDL-C at Month 3
timeFrame: month 3
measure: HDL-C at Month 3
timeFrame: month 3
measure: Triglycerides at Month 3
timeFrame: month 3
measure: Fasting Glucose at Month 3
timeFrame: month 3
measure: Fasting Insulin at Month 3
timeFrame: month 3
measure: HbA1c at Month 3
timeFrame: month 3
measure: Percent Change in Non-HDL-C From Baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Percent Change in Lp(a) From Baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Percent Change in Apoprotein B-100 From Baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Percent Change in Apoprotein A1 From Baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Percent Change in Ratio, ApoB-100/Apo A1 From Baseline to 3 Months
timeFrame: Baseline, 3 months
measure: Percent Change in C-reactive Protein From Baseline to 3 Months
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Rajesh Dash, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Gerri O'Riordan
role: STUDY_DIRECTOR
References: