NCT06098001

Bioavailability Study of Hemp Phenolics

Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Brightseed · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability
• Metabolites
• Excretion

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low dose dietary fiber	Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design
DIETARY_SUPPLEMENT	High dose dietary fiber	Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design

Timeline

• Start date: 2023-09-15
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2023-10-24
• Last updated: 2023-10-24

Locations

1 site across 1 country: United States