Clinical trial NCT06098001: Bioavailability Study of Hemp Phenolics
Official title: Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bioavailability
Metabolites
Excretion
Lead sponsor: Brightseed
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Mérieux NutriSciences
name: University of Arkansas
First posted: 2023-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants receive same treatment in dose escalation design
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Blood concentration of phenolics from 0 to 8 hours
timeFrame: 0 to 8 hours after consumption
Secondary outcomes:
measure: Blood concentration of phenolics 0 to 24 hours
timeFrame: 0 to 24 hours after consumption
measure: Urine concentration of phenolics 24 and 48 hours after consumption
timeFrame: cumulative total phenolics at 24 and 48 hours
measure: Concentration of Phenolic metabolites in blood and urine
timeFrame: Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis
state: Illinois
Study officials:
References: