Bioavailability Study of Hemp Phenolics

Sponsor

Brightseed (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06098001

Collaborator

Biofortis Mérieux NutriSciences (Other), University of Arkansas (Other)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability Metabolites Excretion	Dietary Supplement: Low dose dietary fiber Dietary Supplement: High dose dietary fiber	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants receive same treatment in dose escalation designParticipants receive same treatment in dose escalation design

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber

Actual Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low dose fiber Dose esacalation design	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
Active Comparator: High dose of fiber Dose escalation design which is one arm with low and followed by high dose	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

Arm

Intervention/Treatment

Active Comparator: Low dose fiber

Dose esacalation design

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

Active Comparator: High dose of fiber

Dose escalation design which is one arm with low and followed by high dose

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

Outcome Measures

Primary Outcome Measures

Blood concentration of phenolics from 0 to 8 hours [0 to 8 hours after consumption]

Secondary Outcome Measures

Blood concentration of phenolics 0 to 24 hours [0 to 24 hours after consumption]
Urine concentration of phenolics 24 and 48 hours after consumption [cumulative total phenolics at 24 and 48 hours]
Concentration of Phenolic metabolites in blood and urine [Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biofortis	Addison	Illinois	United States	60101

Sponsors and Collaborators

Brightseed
Biofortis Mérieux NutriSciences
University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brightseed

ClinicalTrials.gov Identifier:

NCT06098001

Other Study ID Numbers:

BIO-2311

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 24, 2023