CompletedNot 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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 completion2026-04-25

View on ClinicalTrials.gov More Tolerability of Hemp Protein trials