Clinical trial NCT07022275: Safety Evaluation of THC-Free Hemp Protein Isolate
Official title: Safety Evaluation of THC-Free Hemp Protein Isolate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tolerability of Hemp Protein
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the safety and tolerability of a THC-free hemp protein supplement in healthy adult volunteers aged 18-65 years who do not use cannabis or hemp-derived products. The main questions this study aims to answer are:

Does twice-daily consumption of 20 grams of Agoge Hemp Protein Powder for 30 days result in detectable levels of THC-COOH, the primary metabolite of THC, in urine samples? Is the supplement well tolerated, and does it affect common clinical safety markers (e.g., liver and kidney function, inflammatory markers)?

This is a single-arm study with no comparison group. All participants will:

* Consume 20 grams of the hemp protein supplement twice daily for 30 days
* Provide blood and urine samples at baseline and Day 30
* Complete weekly surveys assessing adherence, tolerability, and adverse events


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 65 years.
* Able and willing to provide informed consent.
* In good general health as determined by medical history and screening.
* No cannabis or hemp product use within the past 90 days and willingness to avoid consuming other hemp-based or cannabinoid-containing products during the study period.
* Willing to take 20 grams of hemp protein powder, twice a day, for 30 days, complete two blood draws, provide two urine samples, and fill out weekly surveys.

Exclusion Criteria:

* Positive THC-COOH baseline urine test.
* Regular use of any medications that could interfere with THC metabolism.
* History of substance abuse or dependence within the past year.
* Individuals who are pregnant, lactating, or planning a pregnancy within the next 30 days.
* Known allergy or hypersensitivity to cannabis, hemp, or any component of the study product.
* Participants with chronic liver, kidney, or severe cardiovascular disease.
* Participants with dietary restrictions that may prevent them from consuming the study product.
* Current or recent participation in another research study within 14 days of screening.

Primary outcomes:
measure: Presence of THC-COOH in Urine
timeFrame: 30 days
Secondary outcomes:
measure: Number of participants who develop ≥ 1 new clinically-significant laboratory abnormality (hematology, hepatic, or renal) between baseline and day 30.
timeFrame: Baseline (Day 0) and End of Study (Day 30)
measure: Number of participants who experience ≥ 1 treatment-emergent adverse event related to the product
timeFrame: 30 days - Participants complete the REDCap Survey on days 7, 14, 21, and 28
Other outcomes:
Locations:
city: Portland
country: United States
facility: Helfgott Research Institute
state: Oregon
Study officials:
References: