Safety Evaluation of THC-Free Hemp Protein Isolate
Purpose
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
Condition
- Tolerability of Hemp Protein
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Hemp Protein |
Healthy adults consuming 20 grams of Hemp Protein Powder twice a day for 30 days |
|
Recruiting Locations
Portland 5746545, Oregon 5744337 97202
More Details
- NCT ID
- NCT07022275
- Status
- Recruiting
- Sponsor
- National University of Natural Medicine