BioavailabilityNCT06098001
Bioavailability Study of Hemp Phenolics
A study testing Low dose dietary fiber and High dose dietary fiber in people with Bioavailability and Metabolites, run by Brightseed at 1 site in United States.
Trial summary
The aim is to determine the bioavailability of the polyphenol fraction form a commercially available hemp hull fiber at two different amounts in generally healthy adults. Additional objectives include determining specific metabolites produced over a 24 to 48-hour period following the hemp fiber consumption. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability, Metabolites, Excretion
- What is being tested?
- Low dose dietary fiber and High dose dietary fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to Dec 2023
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.50 - 29.99
- non Tobacco or vaping user
- non-user of hemp products within 12 months of first visit
- Willing to stop dietary supplement use within 7 days of visit
- Generally heathy
Who cannot join
- History or presence of clinically important disorders that may affect subjects ability to participate in the study
- Clinically important GI conditions that potentially interfere with evaluation of study product
- Uncontrolled hypertension or unstable use of antihypertensives
- Recent antibiotic use
- extreme dietary habits
- recent or currently on weight loss regimen
Show all 12Show fewer
- Known allergy or sensitivity to the study products
- History or presence of cancer in prior 2 years, except for non-melanoma skin cancer
- History of any major trauma or major surgical event within 2 months of first visit
- Pregnancy or willing to become pregnant during study
- Alcohol abuses
- Exposure to any non-registered drug product within 30 days prior to first visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber
The aim is to determine the bioavailability of the polyphenol fraction form a commercially available hemp hull fiber at two different amounts in generally healthy adults. Additional objectives include determining specific metabolites produced over a 24 to 48-hour period following the hemp fiber consumption. Subjects will consume a study pudding that will be used to deliver a low and a high dose fiber product. Blood samples will be collected to measure background levels of metabolites. At day 0 participants will consume a low dose study product and day 6 the high dose study product and provide blood samples over an 8 hr period after study product consumption, to be followed by a 24 hr blood sample and 48 hr blood sample. Additionally following the low / high dose study product 24 and 48 h urine samples will be collected.
- Conditions
- Bioavailability, Metabolites, Excretion
- Being tested
- Low dose dietary fiber, High dose dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose dietary fiberDietary supplement
Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design
High dose dietary fiberDietary supplement
Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design
| Study group | Role | What they receive |
|---|---|---|
| Low dose fiber | Active comparator | Dose esacalation design Receives: Dietary Supplement: Low dose dietary fiber |
| High dose of fiber | Active comparator | Dose escalation design which is one arm with low and followed by high dose Receives: Dietary Supplement: High dose dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration of phenolics from 0 to 8 hours
Measured: 0 to 8 hours after consumption
Secondary outcomes (3)
Blood concentration of phenolics 0 to 24 hours
Measured: 0 to 24 hours after consumption
Urine concentration of phenolics 24 and 48 hours after consumption
Measured: cumulative total phenolics at 24 and 48 hours
Concentration of Phenolic metabolites in blood and urine
Measured: Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Sep 2023
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants receive same treatment in dose escalation design
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brightseed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences, University of Arkansas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098001
- Sponsor's protocol ID
- BIO-2311
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 24 Oct 2023
- 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 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber
- ClinicalTrials.gov ID
- NCT06098001
- Acronym / sponsor ID
- BIO-2311
- Conditions
- Bioavailability, Metabolites, Excretion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BrightseedIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences, University of Arkansas
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Oct 2023 (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 aim is to determine the bioavailability of the polyphenol fraction form a commercially available hemp hull fiber at two different amounts in generally healthy adults. Additional objectives include determining specific metabolites produced over a 24 to 48-hour period following the hemp fiber consumption. Subjects will consume a study pudding that will be used to deliver a low and a high dose fiber product. Blood samples will be collected to measure background levels of metabolites. At day 0 participants will consume a low dose study product and day 6 the high dose study product and provide blood samples over an 8 hr period after study product consumption, to be followed by a 24 hr blood sample and 48 hr blood sample. Additionally following the low / high dose study product 24 and 48 h urine samples will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receive same treatment in dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Low dose fiber | Active comparator | Dietary Supplement: Low dose dietary fiberDose esacalation design |
| High dose of fiber | Active comparator | Dietary Supplement: High dose dietary fiberDose escalation design which is one arm with low and followed by high dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 18.50 - 29.99
- non Tobacco or vaping user
- non-user of hemp products within 12 months of first visit
- Willing to stop dietary supplement use within 7 days of visit
- Generally heathy
Key exclusion criteria (12 listed)
- History or presence of clinically important disorders that may affect subjects ability to participate in the study
- Clinically important GI conditions that potentially interfere with evaluation of study product
- Uncontrolled hypertension or unstable use of antihypertensives
- Recent antibiotic use
- extreme dietary habits
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 |
|---|---|---|
| Low dose dietary fiberSubjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design | Dietary supplement | Low dose fiber |
| High dose dietary fiberSubjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design | Dietary supplement | High dose of fiber |
Primary outcome
Blood concentration of phenolics from 0 to 8 hours
Time frame: 0 to 8 hours after consumption
3 secondary outcomes
Blood concentration of phenolics 0 to 24 hours
Time frame: 0 to 24 hours after consumption
Urine concentration of phenolics 24 and 48 hours after consumption
Time frame: cumulative total phenolics at 24 and 48 hours
Concentration of Phenolic metabolites in blood and urine
Time frame: Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- 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?
A study testing Low dose dietary fiber and High dose dietary fiber in people with Bioavailability and Metabolites, run by Brightseed 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 5 inclusion and 12 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 Oct 2023. 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?
Blood concentration of phenolics from 0 to 8 hours (time frame: 0 to 8 hours after consumption). 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 Oct 2023.