Safety Evaluation of THC-Free Hemp Protein Isolate

National University of Natural Medicine (NUNM)

Status

Enrolling

Conditions

Tolerability of Hemp Protein

Treatments

Dietary Supplement: Hemp protein powder

Study type

Interventional

Funder types

Other

Identifiers

NCT07022275

BT10124

Details and patient eligibility

About

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

Enrollment

32 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.