Safety Evaluation of THC-Free Hemp Protein Isolate

NCT ID: NCT07022275

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2025-09-25

Brief Summary

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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

Detailed Description

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Conditions

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Tolerability of Hemp Protein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hemp Protein

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

Group Type EXPERIMENTAL

Hemp protein powder

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Hemp protein powder

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Natural Medicine

OTHER

Sponsor Role lead

Responsible Party

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Brice Thompson

Clinical Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helfgott Research Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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BT10124

Identifier Type: -

Identifier Source: org_study_id

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