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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04642742
• Other study ID #: 20209v4
• Status: Enrolling by invitation
• Start date: November 25, 2020
• Est. completion date: November 11, 2021

Study information

• Verified date: November 2020
• Source: Piper Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Chewable plant sterol
Chewable plant sterol (gummy)

Locations

Country	Name	City	State
United States	Piper Biosciences, Inc.	Los Altos	California

Sponsors (1)

Lead Sponsor	Collaborator
Piper Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change in LDL-C from baseline		>10 weeks