Bioavailability Study of Hemp Phenolics

Brightseed

Status: Active, not recruiting

Conditions: Excretion; Metabolites; Bioavailability

Treatments: Dietary Supplement: Low dose dietary fiber; Dietary Supplement: High dose dietary fiber

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06098001

BIO-2311

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Low dose fiber

Active Comparator group

Description:

Dose esacalation design

Treatment:

Dietary Supplement: Low dose dietary fiber

High dose of fiber

Active Comparator group

Description:

Dose escalation design which is one arm with low and followed by high dose

Treatment:

Dietary Supplement: High dose dietary fiber