Safety Evaluation of THC-Free Hemp Protein Isolate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Presence of THC-COOH in Urine
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hemp Protein
Healthy adults consuming 20 grams of Hemp Protein Powder twice a day for 30 days
干预措施: Hemp protein powder (Dietary Supplement)
结局指标
主要结局
Presence of THC-COOH in Urine
时间窗: 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.
次要结局
- 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)
研究者
Brice Thompson
Clinical Investigator
National University of Natural Medicine