Tolerability of Hemp ProteinNCT07022275
Safety Evaluation of THC-Free Hemp Protein Isolate
A study testing Hemp protein powder in people with Tolerability of Hemp Protein, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerability of Hemp Protein
- What is being tested?
- Hemp protein powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2025to 25 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)?
Read more
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
- Being tested
- Hemp protein powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp protein powderDietary supplement
Agoge Universal Hemp Protein Powder - A certified cannabinoid-free hemp protein powder.
| Study group | Role | What they receive |
|---|---|---|
| Hemp Protein | Experimental | Healthy adults consuming 20 grams of Hemp Protein Powder twice a day for 30 days Receives: Dietary Supplement: Hemp protein powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
A 'clinically-significant laboratory abnormality' is defined as any value judged by the principal investigator to be new-onset or ≥ 1 severity grade and rated as at least 'possibly related' to the study product, using CTCAE v5.0 grading where available. CBC - hemoglobin, hematocrit, WBC, or platelet count that shifts from normal at baseline to below/above reference limits by ≥ 1 CTCAE grade. Hepatic Panel - AST or ALT rises to > 2 x upper limit of normal (ULN). Renal Panel - estimated glomerular filtration rate (eGFR) falls to < 60 mL/min/1.73 m^2 or decreases by ≥ 25% from baseline; blood-urea-nitrogen-to-creatinine ratio (BUN:Cr) rises above 20:1 if previously normal. Venous blood is drawn at day 0 and day 30 for CBC, CMP, and calculated eGFR. Results are entered into REDCap, reviewed by a clinician, and coded for relatedness and severity. The study will report n/N (%) of participants meeting any abnormality criterion.
Measured: Baseline (Day 0) and End of Study (Day 30)
Number of participants who experience ≥ 1 treatment-emergent adverse event related to the product
Any self-reported adverse event (AE) deemed at least "possibly related" to the study product. Data collection will occur through a 7-item symptom questionnaire through a REDCap Survey querying about nausea, headache, dizziness, fatigue, skin reactions, gastrointestinal issues, or any other unsolicited symptoms. If any symptom is reported, study staff complete a standardized spontaneous AE reporting form. Each AE is graded for severity (mild, moderate, severe) and relatedness (unrelated, possibly, probably, or definitely) by study staff. The count and proportion of participants experiencing ≥ product-related AE over the 30-day intervention will be reported (n/N [%])
Measured: 30 days - Participants complete the REDCap Survey on days 7, 14, 21, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Mar 2025
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tolerability of Hemp ProteinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brice Thompson, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022275
- Sponsor's protocol ID
- BT10124
- Status last verified
- May 2026
- First submitted
- 30 May 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of THC-Free Hemp Protein Isolate
- ClinicalTrials.gov ID
- NCT07022275
- Acronym / sponsor ID
- BT10124
- Conditions
- Tolerability of Hemp Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemp Protein | Experimental | Dietary Supplement: Hemp protein powderHealthy adults consuming 20 grams of Hemp Protein Powder twice a day for 30 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemp protein powderAgoge Universal Hemp Protein Powder - A certified cannabinoid-free hemp protein powder. | Dietary supplement | Hemp Protein |
Primary outcome
Presence of THC-COOH in Urine
Time frame: 30 days
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.
2 secondary outcomes
Number of participants who develop ≥ 1 new clinically-significant laboratory abnormality (hematology, hepatic, or renal) between baseline and day 30.
Time frame: Baseline (Day 0) and End of Study (Day 30)
Number of participants who experience ≥ 1 treatment-emergent adverse event related to the product
Time frame: 30 days - Participants complete the REDCap Survey on days 7, 14, 21, and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemp protein powder in people with Tolerability of Hemp Protein, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of THC-COOH in Urine (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.