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

Piper Biosciences, Inc.150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Hyperlipidemia

Interventions

Chewable plant sterolDIETARY_SUPPLEMENT

Chewable plant sterol (gummy)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Piper Biosciences, Inc.

Los Altos, California, United States

Outcomes

Primary Outcomes

% change in LDL-C from baseline

Time frame: >10 weeks

Data from ClinicalTrials.gov

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