Cardiovascular Risk FactorPhase 4NCT04030247
Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients
A Phase 4 study testing Plant Sterol in people with Cardiovascular Risk Factor, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Plant Sterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 31 Mar 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a South Asian male or female, ≥18 years of age
- 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%.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Plant Sterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant SterolDrug
Patients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| Plant Sterol | Experimental | South Asian participants with moderate cardiovascular disease risk will receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months. Receives: Drug: Plant Sterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C at Month 3
Measured: month 3
Secondary outcomes (13)
Total Cholesterol at Month 3
Measured: month 3
Calculated LDL-C at Month 3
Measured: month 3
HDL-C at Month 3
Measured: month 3
Triglycerides at Month 3
Measured: month 3
Fasting Glucose at Month 3
Measured: month 3
Fasting Insulin at Month 3
Measured: month 3
HbA1c at Month 3
Measured: month 3
Percent Change in Non-HDL-C From Baseline to 3 Months
% change in baseline measurement non-HDL-C to 3 months
Measured: Baseline, 3 months
Percent Change in Lp(a) From Baseline to 3 Months
% change in baseline measurement Lp(a) to 3 months
Measured: Baseline, 3 months
Percent Change in Apoprotein B-100 From Baseline to 3 Months
% change in baseline measurement Apoprotein B-100 to 3 months
Measured: Baseline, 3 months
Percent Change in Apoprotein A1 From Baseline to 3 Months
% change in baseline measurement Apoprotein A1 to 3 months
Measured: 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
Measured: 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
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start6 Jan 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Piper Biosciences, Inc.
- Responsible party
- Principal investigator, Rajesh Dash, MD PHD, Stanford University
- Investigators
- Rajesh Dash, MD, PhD, Principal investigator, Stanford UniversityGerri O'Riordan, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030247
- Sponsor's protocol ID
- 51046
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2019
- Last updated
- 27 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04030247
- Acronym / sponsor ID
- 51046
- Conditions
- Cardiovascular Risk Factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Piper Biosciences, Inc.
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 27 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plant Sterol | Experimental | Drug: Plant SterolSouth Asian participants with moderate cardiovascular disease risk will receive standard of care in addition to the plant sterol supplement to take twice daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is a South Asian male or female, ≥18 years of age
- 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%.
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant SterolPatients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease. | Drug | Plant Sterol |
Primary outcome
LDL-C at Month 3
Time frame: month 3
13 secondary outcomes
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
Time frame: Baseline, 3 months
Percent Change in Lp(a) From Baseline to 3 Months
Time frame: Baseline, 3 months
Percent Change in Apoprotein B-100 From Baseline to 3 Months
Time frame: Baseline, 3 months
Percent Change in Apoprotein A1 From Baseline to 3 Months
Time frame: Baseline, 3 months
Percent Change in Ratio, ApoB-100/Apo A1 From Baseline to 3 Months
Time frame: Baseline, 3 months
Percent Change in C-reactive Protein From Baseline to 3 Months
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Dash, MD, PhD principal investigator
Stanford University
Gerri O'Riordan study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plant Sterol in people with Cardiovascular Risk Factor, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C at Month 3 (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.