Who is eligible for clinical trial NCT03735420?

Participants must meet the protocol's inclusion criteria for Healthy. The stated age range is 21 Years to 50 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT03735420 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-08-02

Xanthohumol Metabolism and Signature (NCT03735420)

Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: National University of Natural Medicine

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (26 items).

Location: Helfgott Research Institute National University of Natural Medicine — Portland, Oregon

Age range: 21 Years to 50 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Men and Women aged 21-50 years
Willing to take isolated xanthohumol as a dietary supplement for 8 weeks
Willing to have blood drawn semi-weekly and to fast for 10-12 hours before blood draws
Willing and able to collect semi-weekly stool samples at home
Able to speak, read, and understand English
Must be able to provide written informed consent
Non-smokers (including tobacco and Cannabis products, combusted or vaporized)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
History of any chronic disease including, but not limited to: diabetes (type 1 or 2); uncontrolled hypertension; coronary artery disease resulting in angina; cardiovascular disease requiring percutaneous coronary intervention (PCI), bypass, or past myocardial infarction or stroke; blood disease including current anemia; cancer (except non-melanoma skin cancer) within the last year or still requiring chemotherapy or hormonal therapy; chronic kidney disease; liver disease including viral hepatitis, non-alcoholic fatty liver disease, or alcoholic hepatitis/cirrhosis; any immunocompromising condition including human immunodeficiency virus/acquired immunodeficiency syndrome or organ transplant requiring anti-rejection medications; chronic osteoarthritis requiring joint replacement or daily use of NSAIDs; chronic endocrine condition including but not limited to: Cushing's, Addison's, Hashimoto's thyroiditis, Grave's disease, etc.
Body Mass Index (BMI) less than 20 (underweight) or greater than 30 (obese)
Consumption of more than 1 microbrew beer per day
Use of NSAIDs more than once per week for headaches, routine aches/pains, etc.
Use of any prescription drugs, including oral contraceptives (due to potential interference with mechanisms under investigation)
Use of prescription opioids for any reason within the past 3 months
Use of prescription corticosteroids for any reason within the past 3 months
Free of acute viral or bacterial infection, or recent infection within the last 14 days or still requiring prescription medication for treatment
Free of recent acute trauma occurring within the last 14 days
Currently or recently (within last 14 days) taking any dietary supplements containing xanthohumol flavonoids, or other known herbal "anti-inflammatories" including: curcumin, turmeric, fenugreek, hops, rosemary, ginger, white willow, Devil's claw, fish oil (doses\>1 g/day), or quercetin. Candidates will be given the option to "wash out" for 14 days and re-contact the study team.
Currently receiving intravenous nutrition support therapy (or within the last 30 days)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Helfgott Research Institute National University of Natural Medicine — Portland, Oregon

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗