Bioavailability Study of Hemp Phenolics

Not Applicable

Active, not recruiting

• Conditions: Excretion; Bioavailability; Metabolites
• Interventions: Dietary Supplement: High dose dietary fiber; Dietary Supplement: Low dose dietary fiber

• Registration Number: NCT06098001
• Lead Sponsor: Brightseed

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

Not available

Study Timeline

• Study Start: 2023-09-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High dose of fiber	High dose dietary fiber	Dose escalation design which is one arm with low and followed by high dose
Low dose fiber	Low dose dietary fiber	Dose esacalation design

Primary Outcome Measures

Name	Time	Method
Blood concentration of phenolics from 0 to 8 hours	0 to 8 hours after consumption

Secondary Outcome Measures

Name	Time	Method
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
Urine concentration of phenolics 24 and 48 hours after consumption	cumulative total phenolics at 24 and 48 hours
Blood concentration of phenolics 0 to 24 hours	0 to 24 hours after consumption

Trial Locations

Locations (1)

Biofortis; 🇺🇸 Addison, Illinois, United States