Status:
UNKNOWN
Bioavailability Study of Hemp Phenolics
Lead Sponsor:
Brightseed
Collaborating Sponsors:
Biofortis Mérieux NutriSciences
University of Arkansas
Conditions:
Bioavailability
Metabolites
Eligibility:
All Genders
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06098001
Start Date
September 15 2023
End Date
December 1 2023
Last Update
October 24 2023
Active Locations (1)
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1
Biofortis
Addison, Illinois, United States, 60101