Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098001
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-10-05
Brief Title:
Bioavailability Study of Hemp Phenolics
Sponsor:
Brightseed
Organization:
Brightseed
Study Overview
Official Title:
Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None