Safety Evaluation of THC-Free Hemp Protein Isolate

NCT07022275 | Active Not Recruiting

• 1 other identifier: BT10124
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Tolerability of Hemp Protein

Outcome Measures

Primary Outcomes (1)

• Presence of THC-COOH in Urine

  To determine whether THC-COOH, the primary metabolite of THC, is detectable in participants' urine after 30 days of consuming 40 grams of Agoge Hemp Protein Powder.

  30 days

Secondary Outcomes (2)

• Number of participants who develop ≥ 1 new clinically-significant laboratory abnormality (hematology, hepatic, or renal) between baseline and day 30.

  Baseline (Day 0) and End of Study (Day 30)

• Number of participants who experience ≥ 1 treatment-emergent adverse event related to the product

  30 days - Participants complete the REDCap Survey on days 7, 14, 21, and 28

Study Arms (1)

Hemp Protein

EXPERIMENTAL

Healthy adults consuming 20 grams of Hemp Protein Powder twice a day for 30 days

Dietary Supplement: Hemp protein powder

Interventions

Hemp protein powder DIETARY_SUPPLEMENT

Agoge Universal Hemp Protein Powder - A certified cannabinoid-free hemp protein powder.

Hemp Protein

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

Helfgott Research Institute

Portland, Oregon, 97202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 15, 2025
• Study Start: March 15, 2025
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)