Active — Not RecruitingNot Applicable

Safety Evaluation of THC-Free Hemp Protein Isolate

United States32 participantsStarted 2025-03-15

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Presence of THC-COOH in Urine

Timeframe: 30 days

Trial details

NCT IDNCT07022275

SponsorNational University of Natural Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-25