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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

A pilot study to assess the safety and tolerability of oral xanthohumol in humans, to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature.

Research Team

Ryan Bradley, ND, MPH

Principal Investigator

National University of Natural Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+