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Bioavailability Study of Hemp Phenolics

NCT06098001 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-24

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • Brightseed

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06098001 on ClinicalTrials.gov