Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting
- Conditions
- Hyperlipidemia
- Interventions
- Dietary Supplement: Chewable plant sterol
- Registration Number
- NCT04642742
- Lead Sponsor
- Piper Biosciences, Inc.
- Brief Summary
The purpose of this study is to measure the effectiveness of a twice daily plant sterol supplement, which is in a gummy format and packaged with health insights, in reducing LDL-C cholesterol in a real word setting.
- Detailed Description
While the safety and benefits of plant sterol supplements have been established and are incorporated into many lipid lowering guidelines, there have been few prior studies of plant sterol chewables in gummy format among real world subjects. In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation in a real world setting.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Subject is an adult ≥18 years of age who continuously used the sponsor's product for at least 10 weeks prior to the Follow-on Lipid Test
- Baseline Lipid Test conducted within past 2 years
- If smoker, smoking status or frequency has not changed between two lipid test dates
- Subject understands the study procedures and signs forms documenting informed consent
Exclusion Criteria
- Subject was taking a prescription cholesterol-lowering medication or taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin or omega-3 fatty acid supplements at the time of either lipid test
- Subject does not read English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Plant sterol chewable Chewable plant sterol -
- Primary Outcome Measures
Name Time Method % change in LDL-C from baseline >10 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Piper Biosciences, Inc.
🇺🇸Los Altos, California, United States