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Xanthohumol Metabolism and Signature

NCT03735420 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-27

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Xanthohumol

The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.

DRUG

Placebo oral capsule

The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.

Sponsors & Collaborators

  • Oregon State University

    collaborator OTHER

  • Pacific Northwest National Laboratory

    collaborator FED

  • National University of Natural Medicine

    lead OTHER

Principal Investigators

  • Ryan Bradley, ND, MPH · National University of Natural Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2020-05-07
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03735420 on ClinicalTrials.gov