HyperlipidemiaNCT04642742
Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting
An observational study of Hyperlipidemia, run by Piper Biosciences, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Chewable plant sterol
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 11 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Purchasers of OTC plant sterol product who have used the plant sterol product for at least 10 weeks
Who may be able to join
- 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
- Baseline Lipid Test conducted within past 2 years
- If smoker, smoking status or frequency has not changed between two lipid test dates
- Subject understands the study procedures and signs forms documenting informed consent
Who cannot join
- 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
- Subject does not read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Piper Biosciences, Inc.
Los Altos, California, 94024
About this study
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Chewable plant sterol
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewable plant sterolDietary supplement
Chewable plant sterol (gummy)
| Study group | Role | What they receive |
|---|---|---|
| Plant sterol chewable | Not described Receives: Dietary Supplement: Chewable plant sterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change in LDL-C from baseline
Measured: >10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start25 Nov 2020 (estimated)
- Primary completion11 Nov 2021 (estimated)
- Study completion11 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piper Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642742
- Sponsor's protocol ID
- 20209v4
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting
- ClinicalTrials.gov ID
- NCT04642742
- Acronym / sponsor ID
- 20209v4
- Conditions
- Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Piper Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (estimated)
- Primary completion
- 11 Nov 2021 (estimated)
- Study completion
- 11 Nov 2021 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plant sterol chewable | – | Dietary Supplement: Chewable plant sterol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Purchasers of OTC plant sterol product who have used the plant sterol product for at least 10 weeks
Key inclusion criteria (4 listed)
- 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
- Baseline Lipid Test conducted within past 2 years
- If smoker, smoking status or frequency has not changed between two lipid test dates
- Subject understands the study procedures and signs forms documenting informed consent
Key exclusion criteria (2 listed)
- 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
- Subject does not read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewable plant sterolChewable plant sterol (gummy) | Dietary supplement | Plant sterol chewable |
Primary outcome
% change in LDL-C from baseline
Time frame: >10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by Piper Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% change in LDL-C from baseline (time frame: >10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.