HealthyNCT03703388
The Safety and Intake Rate of a Natural Compound Arctigenin in Healthy Men
A study testing Arctigenin in people with Healthy, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Arctigenin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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)
- Conditions
- Healthy
- Being tested
- Arctigenin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArctigeninDietary supplement
Arctigenin capsule
| Study group | Role | What they receive |
|---|---|---|
| Arctigenin 250mg | Experimental | Arctigenin 250mg will be administered for 28 days. Receives: Dietary Supplement: Arctigenin |
| Arctigenin 400mg | Experimental | Arctigenin 400mg will be administered for 28 days. Receives: Dietary Supplement: Arctigenin |
| Arctigenin 500mg | Experimental | Arctigenin 500mg will be administered for 28 days. Receives: Dietary Supplement: Arctigenin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (1)
Bioavailability
- 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start15 Jan 2019
- Primary completion20 Mar 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Drew University of Medicine and Science
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Susanne Henning, PhD, Principal investigator, University of California, Los AngelesPiwen Wang, PhD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703388
- Sponsor's protocol ID
- IRB#: 18-000639
- Status last verified
- Aug 2020
- First submitted
- 9 Oct 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single-arm Dose Escalation Study to Determine the Safety and Bioavailability of a Natural Compound Arctigenin in Healthy Men
- ClinicalTrials.gov ID
- NCT03703388
- Acronym / sponsor ID
- IRB#: 18-000639
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Charles Drew University of Medicine and Science
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arctigenin 250mg | Experimental | Dietary Supplement: ArctigeninArctigenin 250mg will be administered for 28 days. |
| Arctigenin 400mg | Experimental | Dietary Supplement: ArctigeninArctigenin 400mg will be administered for 28 days. |
| Arctigenin 500mg | Experimental | Dietary Supplement: ArctigeninArctigenin 500mg will be administered for 28 days. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArctigeninArctigenin capsule | Dietary supplement | Arctigenin 250mg, Arctigenin 400mg, Arctigenin 500mg |
Primary outcome
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
1 secondary outcome
Bioavailability
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Henning, PhD principal investigator
University of California, Los Angeles
Piwen Wang, PhD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arctigenin in people with Healthy, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.