Bioavailability Study of Hemp Phenolics

Study Overview
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Brief Summary
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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.

Official Title
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Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber

Conditions
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Bioavailability, Metabolites, Excretion

Intervention / Treatment
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* Dietary Supplement: Low dose dietary fiber
* Dietary Supplement: High dose dietary fiber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Participants receive same treatment in dose escalation design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose fiber<br>Dose esacalation design | Dietary Supplement: Low dose dietary fiber<br>* Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design<br>|
| Active Comparator: High dose of fiber<br>Dose escalation design which is one arm with low and followed by high dose | Dietary Supplement: High dose dietary fiber<br>* Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |