ACTIVE_NOT_RECRUITING

Safety Evaluation of THC-Free Hemp Protein Isolate

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Safety Evaluation of THC-Free Hemp Protein Isolate

Quick Facts

Study Start:2025-03-15
Study Completion:2025-09-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07022275

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 to 65 years.
  2. * Able and willing to provide informed consent.
  3. * In good general health as determined by medical history and screening.
  4. * 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.
  5. * 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.
  1. * Positive THC-COOH baseline urine test.
  2. * Regular use of any medications that could interfere with THC metabolism.
  3. * History of substance abuse or dependence within the past year.
  4. * Individuals who are pregnant, lactating, or planning a pregnancy within the next 30 days.
  5. * Known allergy or hypersensitivity to cannabis, hemp, or any component of the study product.
  6. * Participants with chronic liver, kidney, or severe cardiovascular disease.
  7. * Participants with dietary restrictions that may prevent them from consuming the study product.
  8. * Current or recent participation in another research study within 14 days of screening.

Contacts and Locations

Study Locations (Sites)

Helfgott Research Institute
Portland, Oregon, 97202
United States

Collaborators and Investigators

Sponsor: National University of Natural Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-15
Study Completion Date2025-09-25

Study Record Updates

Study Start Date2025-03-15
Study Completion Date2025-09-25

Terms related to this study

Additional Relevant MeSH Terms

  • Tolerability of Hemp Protein