Bioavailability Study of Hemp Phenolics

Bioavailability Clinical Trial

Official title:

Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06098001
• Other study ID #: BIO-2311
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Brightseed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability
• Excretion
• Metabolites

Intervention

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
• High dose dietary fiber
Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design

Locations

Country	Name	City	State
United States	Biofortis	Addison	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Brightseed	Biofortis Mérieux NutriSciences, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentration of phenolics from 0 to 8 hours		0 to 8 hours after consumption
Secondary	Blood concentration of phenolics 0 to 24 hours		0 to 24 hours after consumption
Secondary	Urine concentration of phenolics 24 and 48 hours after consumption		cumulative total phenolics at 24 and 48 hours
Secondary	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