Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting

Piper Biosciences

Status: Unknown

Conditions: Hyperlipidemia

Treatments: Dietary Supplement: Chewable plant sterol

Study type: Observational

Funder types: Industry

Identifiers

NCT04642742

20209v4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Baseline Lipid Test conducted within past 2 years
3. If smoker, smoking status or frequency has not changed between two lipid test dates
4. Subject understands the study procedures and signs forms documenting informed consent

Exclusion criteria

1. 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
2. Subject does not read English

Trial design

150 participants in 1 patient group

Plant sterol chewable

Treatment:

Dietary Supplement: Chewable plant sterol