Xanthohumol for Healthy Subjects

(XMaS Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National University of Natural Medicine

Must not be taking: NSAIDs, Opioids, Corticosteroids, Anticoagulants

Disqualifiers: Chronic disease, Obesity, Recent infection, others

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effects of xanthohumol as a dietary supplement. Xanthohumol, a compound found in hops, is being studied to understand how the body processes it and its impact on biological markers—measurable substances that may indicate health conditions. Participants will receive either xanthohumol or a placebo (a harmless pill with no active ingredient) for comparison. The trial seeks healthy non-smokers who are not taking prescription medications or supplements and are willing to provide blood and stool samples. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking any prescription drugs, including oral contraceptives, to participate in this trial. The trial excludes anyone using prescription medications due to potential interference with the study's mechanisms.

Is there any evidence suggesting that xanthohumol is likely to be safe for humans?

Research has shown that xanthohumol, the compound tested in this trial, is generally safe for people. Current evidence does not indicate any major side effects, though it might cause allergic skin reactions in some individuals. While xanthohumol does not interfere with hormone systems, it could negatively affect certain conditions like advanced prostate cancer. However, this is not a concern for healthy individuals. Overall, available research suggests that xanthohumol is well-tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Xanthohumol is unique because it is a natural compound derived from hops, which are commonly used in brewing beer. Unlike standard treatments for various conditions that often involve synthetic drugs, xanthohumol is being explored for its potential antioxidant and anti-inflammatory properties. Researchers are excited because this compound might offer a more natural alternative with fewer side effects, and it works by targeting oxidative stress and inflammation at a cellular level. This could make it a promising candidate for promoting overall health and wellness.

What evidence suggests that xanthohumol might be an effective treatment for healthy subjects?

Research has shown that xanthohumol, which participants in this trial may receive, is safe and well-tolerated by healthy adults. It possesses strong anti-inflammatory and cell-protective properties, making it useful as an additional treatment for various diseases. Xanthohumol may also help prevent diseases by protecting cells. Furthermore, studies suggest it could benefit conditions related to metabolic syndrome and heart diseases by improving health markers. ^{4 6 7 8 9}

Who Is on the Research Team?

Ryan Bradley, ND, MPH

Principal Investigator

National University of Natural Medicine

Are You a Good Fit for This Trial?

Healthy adults aged 21-50, non-smokers, not on prescription drugs or recent antibiotics, with a BMI between 20 and 30. Participants should not be heavy drinkers or using recreational drugs and must agree to take xanthohumol supplements for 8 weeks while providing regular blood and stool samples.

Inclusion Criteria

I can collect stool samples at home twice a week.

I am between 21 and 50 years old.

I am willing to fast for 10-12 hours and have my blood drawn twice a week.

Exclusion Criteria

Body Mass Index (BMI) less than 20 (underweight) or greater than 30 (obese)

I have not experienced any recent injuries in the past 2 weeks.

I am currently on or recently took blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 24 mg of 98% pure xanthohumol or placebo daily for 8 weeks

8 weeks

Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo oral capsule
• Xanthohumol

Trial Overview The trial is testing the safety of xanthohumol as a dietary supplement in healthy individuals. It aims to understand how it's processed by the body and its effects on biological markers. Some participants will receive xanthohumol while others will get a placebo capsule.

How Is the Trial Designed?

Group I: Xanthohumol Experimental Treatment 1 Intervention

Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.

Group II: Placebo oral capsule Placebo Group 1 Intervention

Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

Oregon State University

Collaborator

Trials

51

Recruited

8,300+

Pacific Northwest National Laboratory

Collaborator

Trials

10

Recruited

3,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8221389/

Xanthohumol Microbiome and Signature in ... In summary, 24 mg daily XN taken over an eight-week period was safe and well-tolerated by healthy adults. The results of the work reported here will inform ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04769-2

Xanthohumol microbiome and signature in healthy adults (the ... The main objective is to examine the clinical safety and subjective tolerability of xanthohumol in healthy adults compared to placebo.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163725824001864

Is there a place for natural agents with anti-inflammatory ... Xanthohumol is safe and effective as an adjuvant therapy for various diseases attributed to its strong anti-inflammatory and antioxidative properties that can ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674025/

Antioxidant Potential of Xanthohumol in Disease Prevention XN is known as a potent antioxidant compound, which, according to current research, has the potential to prevent and inhibit the development of diseases.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mnfr.202100831

Bioavailability and Cardiometabolic Effects of Xanthohumol ... Increasing evidence suggests that xanthohumol positively affects biomarkers associated with metabolic syndrome and cardiovascular diseases (CVDs).

6. carlroth.com carlroth.com/medias/SDB-2828-GB-EN.pdf?context=bWFzdGVyfHNlY3VyaXR5RGF0YXNoZWV0c3wyMzMzMTl8YXBwbGljYXRpb24vcGRmfGFHSTBMMmd4Wmk4NU1UYzFNalUxTnpjM016RXdMMU5FUWw4eU9ESTRYMGRDWDBWT0xuQmtaZ3w5ZjUyODU5MjQxNWNlZWU3MmZlYzg5OWRhYzIzMzU1MzFjMzRiZjQ5NzgxYjUxODMzOGZhNTFhMmY2NzM0NTMy

Safety Data Sheet: Xanthohumol Does not contain an endocrine disruptor (ED) at a concentration of ≥ 0,1%. 12.7 Other adverse effects. Data are not available. SECTION 13: Disposal ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/15399m.pdf

Safety Data Sheet Aquatic Acute 1. H400 Very toxic to aquatic life. d. ~GHS07. Sensitization - skin 1 H317 May cause an allergic skin reaction. · ...

8. barthhaasx.com barthhaasx.com/fileadmin/user_upload/downloads/sharepoint/xanthohumol-hop-extract-sds.pdf

Xanthohumol Extract 10.4 Conditions to Avoid. No safety-relevant information available. Oxidation-promoting conditions such as heat and UV light have a quality-reducing effect.

9. carlroth.com carlroth.com/medias/SDB-NE35-MT-EN.pdf?context=bWFzdGVyfHNlY3VyaXR5RGF0YXNoZWV0c3wyMjU2MDN8YXBwbGljYXRpb24vcGRmfHNlY3VyaXR5RGF0YXNoZWV0cy9oYzQvaGZlLzg5OTU1OTUzNTQxNDIucGRmfDY4N2VkMWEzOGRkMDA1ZGZlYjcyZmNlNzcxNTE1OGZmYTAyYTFiZjZjMGQ1Mzg1NzgxYTgxYWY0NTkxZGViMDY

Safety Data Sheet: Xanthohumol Call a doctor if you feel unwell. 4.2. Most important symptoms and effects, both acute and delayed. Symptoms and effects are not known to date. 4.3.