General WellbeingNCT04026672
Hemp Oil + User Experience Study
An observational study of General Wellbeing and Gastrointestinal Health, run by Thorne HealthTech, Inc at 1 site in United States.
Trial summary
Presented as an online survey, this study seeks to better understand how Thorne customers are using and experiencing the new Hemp Oil + product and how they feel it compares in the marketplace. Hemp Oil + is a combination product with a proprietary blend of hemp, clove, black pepper, hops, and rosemary extracts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Wellbeing, Gastrointestinal Health, Physical Discomfort
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 4 Feb 2020
- 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
- Adult, Older adult
Study population: People who have purchased Hemp Oil +
Who may be able to join
- Has personally used at least one bottle (30 gelcaps) of Hemp Oil +
- Provides consent to participate in the study
Who cannot join
- Cannot access or use the electronic survey for any reason
- Was pregnant or nursing when taking Hemp Oil +
- Is a Thorne employee not willing to participate without compensation
Trial locations and contacts
1 site in 1 country.
United States1 site
Online Survey for Thorne Research, Inc.
Summerville, South Carolina, 29486
About this study
Official title: Hemp Oil + User Experience Study: A Retrospective, Non-Interventional Study to Assess Consumer Experience and the Impact of Hemp Oil + on Quality of Life
Presented as an online survey, this study seeks to better understand how Thorne customers are using and experiencing the new Hemp Oil + product and how they feel it compares in the marketplace. Hemp Oil + is a combination product with a proprietary blend of hemp, clove, black pepper, hops, and rosemary extracts. People who have independently elected to purchase and use Hemp Oil + before the study starts will be invited to voluntarily participate. If they meet study requirements and give consent they will answer questions online about their experience with Hemp Oil +. Questions address general demographics and wellness, general impressions of the product, how it compares to other products, and any effect it has had on their gastrointestinal health, physical discomfort, sleep, and mood. The survey is expected to take 15-30 min of participant time. Data will be analyzed to determine whether the customer experience with Hemp Oil + is as favorable as it seems from anecdotal reports. Analysis will also be conducted to find patterns that can inform future studies, marketing, and customer education efforts.
- Conditions
- General Wellbeing, Gastrointestinal Health, Physical Discomfort, Sleep, Mood
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess impact to overall quality of life (QoL) after taking Hemp Oil +
Questionnaire gathering data from the past 30 or more days
Measured: 1 Day
Secondary outcomes (2)
Assess impact to specific QoL factors - GI health, mood, sleep, physical discomfort - after taking Hemp Oil +
Questionnaire gathering data from the past 30 or more days
Measured: 1 Day
Gain insight into user perspective on product quality, efficacy, and rationale for continuing/discontinuing use
Questionnaire gathering data from the past 30 or more days
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start22 Jan 2020
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General WellbeingStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorne HealthTech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Jacques, ND, Principal investigator, Thorne ResearchSheena Smith, MS, Principal investigator, Thorne Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026672
- Sponsor's protocol ID
- Hemp-PM001
- Status last verified
- Feb 2020
- First submitted
- 28 Jun 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemp Oil + User Experience Study: A Retrospective, Non-Interventional Study to Assess Consumer Experience and the Impact of Hemp Oil + on Quality of Life
- ClinicalTrials.gov ID
- NCT04026672
- Acronym / sponsor ID
- Hemp-PM001
- Conditions
- General Wellbeing, Gastrointestinal Health, Physical Discomfort, Sleep, Mood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Thorne HealthTech, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 19 Jul 2019 (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.
Presented as an online survey, this study seeks to better understand how Thorne customers are using and experiencing the new Hemp Oil + product and how they feel it compares in the marketplace. Hemp Oil + is a combination product with a proprietary blend of hemp, clove, black pepper, hops, and rosemary extracts. People who have independently elected to purchase and use Hemp Oil + before the study starts will be invited to voluntarily participate. If they meet study requirements and give consent they will answer questions online about their experience with Hemp Oil +. Questions address general demographics and wellness, general impressions of the product, how it compares to other products, and any effect it has had on their gastrointestinal health, physical discomfort, sleep, and mood. The survey is expected to take 15-30 min of participant time. Data will be analyzed to determine whether the customer experience with Hemp Oil + is as favorable as it seems from anecdotal reports. Analysis will also be conducted to find patterns that can inform future studies, marketing, and customer education efforts.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People who have purchased Hemp Oil +
Key inclusion criteria (2 listed)
- Has personally used at least one bottle (30 gelcaps) of Hemp Oil +
- Provides consent to participate in the study
Key exclusion criteria (3 listed)
- Cannot access or use the electronic survey for any reason
- Was pregnant or nursing when taking Hemp Oil +
- Is a Thorne employee not willing to participate without compensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess impact to overall quality of life (QoL) after taking Hemp Oil +
Time frame: 1 Day
Questionnaire gathering data from the past 30 or more days
2 secondary outcomes
Assess impact to specific QoL factors - GI health, mood, sleep, physical discomfort - after taking Hemp Oil +
Time frame: 1 Day
Gain insight into user perspective on product quality, efficacy, and rationale for continuing/discontinuing use
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
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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.
Jacqueline Jacques, ND principal investigator
Thorne Research
Sheena Smith, MS principal investigator
Thorne Research
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 General Wellbeing and Gastrointestinal Health, run by Thorne HealthTech, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess impact to overall quality of life (QoL) after taking Hemp Oil + (time frame: 1 Day). 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 10 Feb 2020.