The Safety and Intake Rate of a Natural Compound Arctigenin in Healthy Men

NCT03703388 | Completed

• 1 other identifier: IRB#: 18-000639
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bioavailability

  28 days

Study Arms (3)

Arctigenin 250mg

EXPERIMENTAL

Arctigenin 250mg will be administered for 28 days.

Dietary Supplement: Arctigenin

Arctigenin 400mg

EXPERIMENTAL

Arctigenin 400mg will be administered for 28 days.

Dietary Supplement: Arctigenin

Arctigenin 500mg

EXPERIMENTAL

Arctigenin 500mg will be administered for 28 days.

Dietary Supplement: Arctigenin

Interventions

Arctigenin DIETARY_SUPPLEMENT

Arctigenin capsule

Arctigenin 250mg; Arctigenin 400mg; Arctigenin 500mg

Eligibility Criteria

• Age: 20 Years - 75 Years
• Gender Eligibility Details: Born male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects consent to participate in the trial;
• The subject is 20-75 years of age;
• The subject is in healthy condition;
• 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.

You may not qualify if:

• History of hepatitis or liver dysfunction;
• History of kidney disease or dysfunction;
• Ongoing alcohol abuse;
• Significant medical or psychiatric conditions that would make the patient a poor protocol candidate;
• Prior sensitivity or allergic reaction to arctigenin-containing products or supplements;
• Allergies to multiple food items or nutritional supplements;
• Taking antibiotics, anti-diabetic medicines, anti-cancer medicine, LHRH agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Charles Drew University of Medicine and Science: collaborator

Study Sites (1)

UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

arctigenin

Study Officials

• Susanne Henning, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Piwen Wang, PhD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: January 15, 2019
• Primary Completion: March 20, 2020
• Study Completion: July 15, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)