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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
Stanford University
Stanford, California, United States
LDL-C at Month 3
Time frame: month 3
Total Cholesterol at Month 3
Time frame: month 3
Calculated LDL-C at Month 3
Time frame: month 3
HDL-C at Month 3
Time frame: month 3
Triglycerides at Month 3
Time frame: month 3
Fasting Glucose at Month 3
Time frame: month 3
Fasting Insulin at Month 3
Time frame: month 3
HbA1c at Month 3
Time frame: month 3
Percent Change in Non-HDL-C From Baseline to 3 Months
% change in baseline measurement non-HDL-C to 3 months
Time frame: Baseline, 3 months
Percent Change in Lp(a) From Baseline to 3 Months
% change in baseline measurement Lp(a) to 3 months
Time frame: Baseline, 3 months
Percent Change in Apoprotein B-100 From Baseline to 3 Months
% change in baseline measurement Apoprotein B-100 to 3 months
Time frame: Baseline, 3 months
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Percent Change in Apoprotein A1 From Baseline to 3 Months
% change in baseline measurement Apoprotein A1 to 3 months
Time frame: Baseline, 3 months
Percent Change in Ratio, ApoB-100/Apo A1 From Baseline to 3 Months
% change in baseline measurement ratio, ApoB-100/Apo A1 to 3 months
Time frame: Baseline, 3 months
Percent Change in C-reactive Protein From Baseline to 3 Months
% change in baseline measurement in C-reactive protein to 3 months
Time frame: Baseline, 3 months