An interventional study of Low dose dietary fiber and High dose dietary fiber in Bioavailability, Metabolites and Excretion, sponsored by Brightseed. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Brightseed · Not applicable, Interventional, and Basic science
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.
Brightseed is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose esacalation design
Dietary Supplement: Low dose dietary fiber
Dose escalation design which is one arm with low and followed by high dose
Dietary Supplement: High dose dietary fiber
Subjects will receive a low dose or high dose of the dietary fiber product in a dose esacalation design
Subjects will receive a low dose or high dose of the dietary fiber product in a dose escalation design
Blood concentration of phenolics from 0 to 8 hours
Time frame: 0 to 8 hours after consumption
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brightseed