Bioavailability Study of Hemp Phenolics

NCT06098001 | Unknown

• 1 other identifier: BIO-2311
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability; Metabolites; Excretion

Outcome Measures

Primary Outcomes (1)

• Blood concentration of phenolics from 0 to 8 hours

  0 to 8 hours after consumption

Secondary Outcomes (3)

• 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

Study Arms (2)

Low dose fiber

ACTIVE COMPARATOR

Dose esacalation design

Dietary Supplement: Low dose dietary fiber

High dose of fiber

ACTIVE COMPARATOR

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

Dietary Supplement: High dose dietary fiber

Interventions

Low dose dietary fiber DIETARY_SUPPLEMENT

Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design

Low dose fiber

High dose dietary fiber DIETARY_SUPPLEMENT

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

High dose of fiber

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brightseed: lead
• Biofortis Mérieux NutriSciences: collaborator
• University of Arkansas: collaborator

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants receive same treatment in dose escalation design

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 24, 2023
• Study Start: September 15, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)