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

August 3, 2020 updated by: Zhaoping Li, University of California, Los Angeles

A Phase I Single-arm Dose Escalation Study to Determine the Safety and Bioavailability of a Natural Compound Arctigenin in Healthy Men

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Phytochemicals are bioactive natural compounds extracted from plants. Phytochemicals have been considered as a major resource for developing non-toxic agents in prevention and treatment of chronic diseases, such as diabetes and cancer. However, most phytochemicals have low absorption rates, and the dose levels necessary for their beneficial effects can barely be achieved in the body after oral consumption, which limits their effect in humans. Therefore it is in urgent need to identify phytochemicals of higher uptake rate (or termed bioavailability). Arctigenin is a novel anti-inflammatory lignan mainly existing in the seeds of the herb Arctium lappa. This herb particularly its seeds has been widely used in traditional Chinese medicine to treat inflammation-related diseases such as cold, sore throat, and cough. The anti-cancer activity of arctigenin has recently been identified in cultured cancer cells and in animal models of several cancers. In prostate cancer, we found that arctigenin is highly effective in inhibition of the growth of cultured prostate cancer cells, while without affecting normal cells. The strong anti-tumor activity of arctigenin was further confirmed in our animal studies with prostate cancer mouse models. By analysis of blood concentrations of arctigenin, we found that the effective dose of arctigenin as observed in cultured cancer cells was achievable in mouse blood after consumption of arctigenin at a safe level, which suggests that the bioavailability of arctigenin is adequately high for its anti-cancer effect in organisms. We therefore propose a phase I one-arm dose escalation study to confirm the safety and bioavailability of arctigenin in healthy men, and to determine the dosage for future phase II studies in prostate cancer prevention. The study will use the traditional 3+3 design, which is the most widely used phase I design in oncology. Three dose levels of arctigenin will be tested, and participants will receive two capsules of arctigenin per day for 28 days, each capsule containing 250 mg of arctigenin. Initially there will be three participants on each dose level. If there is no dose-limiting toxicity (DLT) observed in any participant, the dose will be escalated to the next level. If DLT is observed in one or two participants, three more participants will be added. If DLT is observed in one or two participants out of the six, the dose will be escalated to the next level. If DLT is observed in three or more participants of the six, the previous dose level will be considered as the maximally tolerated dose (MTD), and three more patients will be added to the MTD group for a more accurate evaluation of the safety. The estimated MTD is the highest dose level with observed toxicity rate less than 0.33. Blood samples will be collected at baseline, during week 2 and on the last day of the study. Urine samples will be collected once a week during the intervention. On the last day of the intervention (Day 28) we will perform a single dose challenge with arctigenin and collect blood at baseline and at 1h, 2h, and 3h after arctigenin consumption in the morning. Arctigenin and its glucuronide will be analyzed in blood and urine using high performance liquid chromatography (HPLC)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arctigenin 250mg
Arctigenin 250mg will be administered for 28 days.
Dietary supplement: Arctigenin
Arctigenin capsule
Experimental: Arctigenin 400mg
Arctigenin 400mg will be administered for 28 days.
Dietary supplement: Arctigenin
Arctigenin capsule
Experimental: Arctigenin 500mg
Arctigenin 500mg will be administered for 28 days.
Dietary supplement: Arctigenin
Arctigenin capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: 28 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bioavailability
Time Frame: 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charles Drew University of Medicine and Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susanne Henning, PhD, University of California, Los Angeles
  • Principal Investigator: Piwen Wang, PhD, Charles Drew University of Medicine and Science

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#: 18-000639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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