NCT03735420

Xanthohumol Metabolism and Signature

Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National University of Natural Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a double-masked, placebo controlled, randomized clinical trial of xanthohumol, which is a constituent of hops (Humulus lupulus). Hops and its constituents have a long history of use for a variety of conditions. However, knowledge is limited regarding the measurable biological markers of human exposure, and the role of xanthohumol metabolism by microorganisms present in the gut. This information is necessary for the development of xanthohumol as a potential therapeutic intervention in conditions such as inflammatory bowel disease.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-12
• Primary completion: 2020-05-07
• Completion: 2024-12-31
• First posted: 2018-11-08
• Last updated: 2024-08-27
• Results posted: 2022-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study