Safety Evaluation of THC-Free Hemp Protein Isolate

Safety Evaluation of THC-Free Hemp Protein Isolate

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

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.