Bioavailability, Excretion, Metabolites
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLow dose dietary fiber
Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design
DIETARY_SUPPLEMENTHigh dose dietary fiber
Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design
Sponsors
Biofortis Mérieux NutriSciences
University of Arkansas
Brightseed
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants receive same treatment in dose escalation design
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of phenolics from 0 to 8 hours | 0 to 8 hours after consumption |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed