Bioavailability Study of Hemp Phenolics

Brightseed10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bioavailability Metabolites Excretion

Interventions

Low dose dietary fiberDIETARY_SUPPLEMENT

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

High dose dietary fiberDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Blood concentration of phenolics from 0 to 8 hours

Time frame: 0 to 8 hours after consumption

Secondary Outcomes

Blood concentration of phenolics 0 to 24 hours

Time frame: 0 to 24 hours after consumption

Urine concentration of phenolics 24 and 48 hours after consumption

Time frame: cumulative total phenolics at 24 and 48 hours

Concentration of Phenolic metabolites in blood and urine

Time frame: Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption