Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients

NCT ID: NCT04030247

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2021-03-31

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.

Conditions

Cardiovascular Risk Factor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plant Sterol

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.

Group Type: EXPERIMENTAL

Plant Sterol

Intervention Type: DRUG

Patients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.

Interventions

Plant 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Piper Biosciences, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Rajesh Dash, MD PHD

Director, SSATHI & CardioClick Clinics; Associate Professor of Cardiovascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajesh Dash, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Gerri O'Riordan

Role: STUDY_DIRECTOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

51046

Identifier Type: -

Identifier Source: org_study_id