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

NCT ID: NCT04642742

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-25

Study Completion Date

2021-11-11

Brief Summary

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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

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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.

Conditions

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Hyperlipidemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Plant sterol chewable

Chewable plant sterol

Intervention Type DIETARY_SUPPLEMENT

Chewable plant sterol (gummy)

Interventions

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Chewable plant sterol

Chewable plant sterol (gummy)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Piper Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Piper Biosciences, Inc.

Los Altos, California, United States

Site Status

Countries

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United States

Other Identifiers

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20209v4

Identifier Type: -

Identifier Source: org_study_id