Bioavailability Study of Hemp Phenolics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Bioavailability Metabolites Excretion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants receive same treatment in dose escalation design

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low dose fiber

Dose esacalation design

Group Type ACTIVE_COMPARATOR

Low dose dietary fiber

Intervention Type DIETARY_SUPPLEMENT

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

High dose of fiber

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

Group Type ACTIVE_COMPARATOR

High dose dietary fiber

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Low dose dietary fiber

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes