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

NCT04030247 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 51046
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• LDL-C at Month 3

  month 3

Secondary Outcomes (13)

• 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

Study Arms (1)

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.

Drug: Plant Sterol

Interventions

Plant Sterol 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.

Plant Sterol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Piper Biosciences, Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Interventions

Phytosterols

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Results Point of Contact

• Title: Rajesh Dash, MD
• Organization: Stanford University

rdash@stanford.edu

650-725-7087

Study Officials

• Rajesh Dash, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Gerri O'Riordan

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, SSATHI & CardioClick Clinics; Associate Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: January 6, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)