Cardiovascular Risk Factor
Conditions
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.
Interventions
DRUGPlant Sterol
Patients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
Sponsors
Piper Biosciences, Inc.
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C at Month 3 | month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol at Month 3 | month 3 | — |
| Calculated LDL-C at Month 3 | month 3 | — |
| HDL-C at Month 3 | month 3 | — |
| Triglycerides at Month 3 | month 3 | — |
| Fasting Glucose at Month 3 | month 3 | — |
| Fasting Insulin at Month 3 | month 3 | — |
| HbA1c at Month 3 | month 3 | — |
| Percent Change in Non-HDL-C From Baseline to 3 Months | Baseline, 3 months | % change in baseline measurement non-HDL-C to 3 months |
| Percent Change in Lp(a) From Baseline to 3 Months | Baseline, 3 months | % change in baseline measurement Lp(a) to 3 months |
| Percent Change in Apoprotein B-100 From Baseline to 3 Months | Baseline, 3 months | % change in baseline measurement Apoprotein B-100 to 3 months |
| Percent Change in Apoprotein A1 From Baseline to 3 Months | Baseline, 3 months | % change in baseline measurement Apoprotein A1 to 3 months |
| Percent Change in Ratio, ApoB-100/Apo A1 From Baseline to 3 Months | Baseline, 3 months | % change in baseline measurement ratio, ApoB-100/Apo A1 to 3 months |
| Percent Change in C-reactive Protein From Baseline to 3 Months | Baseline, 3 months | % change in baseline measurement in C-reactive protein to 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plant Sterol South Asian participants with moderate cardiovascular disease risk receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Plant Sterol |
|---|---|
| Age, Continuous | 45.33 years STANDARD_DEVIATION 8.3 |
| Calculated LDL-C | 154 mg/dL STANDARD_DEVIATION 24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fasting Glucose | 98 mg/dL STANDARD_DEVIATION 11 |
| Fasting Insulin | 11.3 mcU/mL STANDARD_DEVIATION 7 |
| Hemoglobin A1C (HbA1c) | 5.5 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.3 |
| High Density Lipoprotein-Cholesterol (HDL-C) | 50 mg/dL STANDARD_DEVIATION 15 |
| Low Density Lipoprotein-Cholesterol (LDL-C) | 154 mg/dL STANDARD_DEVIATION 24 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 33 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 33 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 12 Participants |
| Total Cholesterol | 221 mg/dL STANDARD_DEVIATION 34 |
| Triglycerides | 137 mg/dL STANDARD_DEVIATION 52 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
LDL-C at Month 3
Time frame: month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | LDL-C at Month 3 | 145 mg/dL | Standard Deviation 20 |
Comparison: Difference between baseline and month 3p-value: 0.03t-test, 2 sided
Secondary
Calculated LDL-C at Month 3
Time frame: month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | Calculated LDL-C at Month 3 | 145 mg/dL | Standard Deviation 20 |
Comparison: Difference between baseline and month 3p-value: 0.03t-test, 2 sided
Secondary
Fasting Glucose at Month 3
Time frame: month 3
Population: Participants with available data are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | Fasting Glucose at Month 3 | 96 mg/dL | Standard Deviation 8 |
Comparison: Difference between baseline and month 3p-value: 0.4t-test, 2 sided
Secondary
Fasting Insulin at Month 3
Time frame: month 3
Population: Participants with available data are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | Fasting Insulin at Month 3 | 10.2 mcU/mL | Standard Deviation 5.9 |
Secondary
HbA1c at Month 3
Time frame: month 3
Population: Participants with available data are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | HbA1c at Month 3 | 5.5 Percentage of glycosylated hemoglobin | Standard Deviation 0.2 |
Comparison: Difference between baseline and month 3p-value: 0.6t-test, 2 sided
Secondary
HDL-C at Month 3
Time frame: month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | HDL-C at Month 3 | 50 mg/dL | Standard Deviation 13 |
Comparison: Difference between baseline and month 3p-value: 0.9t-test, 2 sided
Secondary
Percent Change in Apoprotein A1 From Baseline to 3 Months
% change in baseline measurement Apoprotein A1 to 3 months
Time frame: Baseline, 3 months
Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.
Secondary
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
Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.
Secondary
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
Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.
Secondary
Percent Change in Lp(a) From Baseline to 3 Months
% change in baseline measurement Lp(a) to 3 months
Time frame: Baseline, 3 months
Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.
Secondary
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
Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.
Secondary
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
Population: Data were not collected for this outcome measure due to changes in study conduct during the Covid-19 emergency and due to cost of testing that would have been borne by study participants.
Secondary
Total Cholesterol at Month 3
Time frame: month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | Total Cholesterol at Month 3 | 216 mg/dL | Standard Deviation 29 |
Comparison: Difference between baseline and month 3p-value: 0.16t-test, 2 sided
Secondary
Triglycerides at Month 3
Time frame: month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plant Sterol | Triglycerides at Month 3 | 142 mg/dL | Standard Deviation 58 |
Comparison: Difference between baseline and month 3p-value: 0.5t-test, 2 sided