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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04642742
Enrollment
150
Registered
2020-11-24
Start date
2020-11-25
Completion date
2021-11-11
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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.

Interventions

DIETARY_SUPPLEMENTChewable plant sterol

Chewable plant sterol (gummy)

Sponsors

Piper Biosciences, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
% change in LDL-C from baseline>10 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026