← Back to Search

Polyphenol

Xanthohumol for Healthy Subjects (XMaS Trial)

Phase 1
Waitlist Available
Led By Ryan Bradley, ND, MPH
Research Sponsored by National University of Natural Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to collect semi-weekly stool samples at home
Men and Women aged 21-50 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Awards & highlights

XMaS Trial Summary

This trial tests if a plant-based compound is safe and tolerated by people and how it's processed by the body.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is an initial study assessing safety, potential side effects are being investigated but may include digestive discomfort or changes in liver function tests due to the unknown impact of xanthohumol.

XMaS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can collect stool samples at home twice a week.
Select...
I am between 21 and 50 years old.

XMaS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 4 weeks, 6 weeks, and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 4 weeks, 6 weeks, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Plasma Inflammatory Markers
Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]
Secondary outcome measures
Alanine Aminotransferase (ALT)
Aspartate Aminotransferase (AST)
Bile Acids
+13 more

XMaS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: XanthohumolExperimental Treatment1 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 capsulePlacebo Group1 Intervention
Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanthohumol
2011
N/A
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National University of Natural MedicineLead Sponsor
29 Previous Clinical Trials
1,297 Total Patients Enrolled
Oregon State UniversityOTHER
49 Previous Clinical Trials
8,351 Total Patients Enrolled
Pacific Northwest National LaboratoryFED
9 Previous Clinical Trials
3,746 Total Patients Enrolled

Media Library

Xanthohumol (Polyphenol) Clinical Trial Eligibility Overview. Trial Name: NCT03735420 — Phase 1
Healthy Subjects Research Study Groups: Xanthohumol, Placebo oral capsule
Healthy Subjects Clinical Trial 2023: Xanthohumol Highlights & Side Effects. Trial Name: NCT03735420 — Phase 1
Xanthohumol (Polyphenol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03735420 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons aged 35 or older being included in the experiment?

"This medical trial is accepting patients who are between 21 and 50 years of age."

Answered by AI

Has Xanthohumol been investigated in other scientific research?

"At present, there is one clinical trial in progress looking into the potential of Xanthohumol. None are at Phase 3 yet; however, all studies concerning this compound originate from Portland, Oregon with a single location running tests for it."

Answered by AI

Does Xanthohumol pose any health risks to humans?

"The safety of Xanthohumol has been tentatively assessed and given a rating of 1 due to the relatively nascent stage (Phase 1) in which the drug currently resides. This means that there is limited data available with regards to both its efficacy and safety."

Answered by AI

What is the capacity of this clinical trial and how many participants are currently enrolled?

"Unfortunately, this clinical trial has concluded its recruitment activities. It was initially posted on August 12th 2019 and last updated on March 22nd 2023. If you're looking for alternative trials, 831 of them are presently accepting healthy participants and 1 is seeking those with Xanthohumol experience."

Answered by AI

Are individuals still being enrolled in this experiment?

"According to the clinicaltrials.gov website, this particular trial is no longer actively seeking patients for enrollment; it was initially posted on August 12th 2019 with its last update occurring March 22nd 2023. Fortunately, there are 832 other trials that presently require participants."

Answered by AI

What aims does this research endeavor hope to accomplish?

"The primary measure of this trial's success will be the observed change in Plasma Inflammatory Markers at intervals of Baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks. Secondary outcomes incorporate Complete Blood Count Abnormals (i.e., number of participants with an abnormal value compared to the total quantity), % new abnormals if any such values are noted according to Quest Diagnostics criteria, Mean Corpuscular Hemoglobin mean changes from baseline over time period specified earlier and finally Mean Corpuscular Volume calculated similarly as described before."

Answered by AI

For whom is this investigation accessible?

"The trial is open to applicants aged 21-50 who meet healthy subject criteria. A total of 30 participants are being accepted into the study."

Answered by AI
~5 spots leftby Apr 2025