Bioavailability Study of Hemp Phenolics

Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bioavailability; Metabolites; Excretion
• Intervention / Treatment: Dietary supplement: Low dose dietary fiber; Dietary supplement: High dose dietary fiber

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood concentration of phenolics from 0 to 8 hours	0 to 8 hours after consumption

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Brightseed
• Collaborators: University of Arkansas; Biofortis Mérieux NutriSciences

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No