Healthy Clinical Trial
Official title:
A Phase I Single-arm Dose Escalation Study to Determine the Safety and Bioavailability of a Natural Compound Arctigenin in Healthy Men
Verified date | August 2020 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to determine if consuming arctigenin, a natural compound from a Chinese herb called Arctium lappa (commonly called greater burdock), is safe, and to measure the intake level of arctigenin in blood. Arctigenin is being studied by researchers for potential health benefits such as helping to lower the risk of inflammation and cancer. A human study has been done measuring the uptake of arctigenin into blood after consumption of the herb extract containing arctigenin, and found no toxicity. Studies in mice demonstrated that consumption of arctigenin in pure form at a safe level is highly effective in inhibition of prostate cancer growth. Therefore, this study is designed to evaluate the safety and uptake rate of pure arctigenin in humans, which may be potentially used in the future for prostate cancer prevention.
Status | Completed |
Enrollment | 21 |
Est. completion date | July 15, 2020 |
Est. primary completion date | March 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Subjects consent to participate in the trial; 2. The subject is 20-75 years of age; 3. The subject is in healthy condition; 4. The subject agrees to stop consuming or using arctigenin-containing products and supplement throughout the entire intervention period except for arctigenin capsules provided during study intervention. Exclusion Criteria: 1. History of hepatitis or liver dysfunction; 2. History of kidney disease or dysfunction; 3. Ongoing alcohol abuse; 4. Significant medical or psychiatric conditions that would make the patient a poor protocol candidate; 5. Prior sensitivity or allergic reaction to arctigenin-containing products or supplements; 6. Allergies to multiple food items or nutritional supplements; 7. Taking antibiotics, anti-diabetic medicines, anti-cancer medicine, LHRH agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187 | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Charles Drew University of Medicine and Science |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose | To determine the maximum tolerated dose (or recommended dose) for future phase II studies by assessing the dose-limiting toxicities related to arctigenin consumption | 28 days | |
Secondary | Bioavailability | 2. To determine the bioavailability of arctigenin by measuring the concentrations of arctigenin and its glucuronide conjugates in serum collected before (T=0) and one hour (T1), two hours (T=2), and three hours (T=3) after the intake of a morning dose of arctigenin on Day 28 | 28 days |
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