NCT04030247

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

Impact of Plant Sterol Supplement on LDL-C Lowering in Low-to-Moderate Risk South Asian Patients Participating in a Cardiovascular Disease Prevention Program

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2020-01-06
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-07-23
• Last updated: 2022-04-27
• Results posted: 2022-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study