Bioavailability Study of Hemp Phenolics
Status unconfirmed · Not applicable
Conditions studied: Bioavailability, Metabolites, Excretion
In brief
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.
Key facts
- Study ID
- NCT06098001
- Run by
- Brightseed
- People needed
- 10
- Starts
- 2023-09-15
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2023-10-24
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Biofortis — Addison, Illinois, United States
Full record on ClinicalTrials.gov
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