Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial

Ryan Bradley; Blake O. Langley; Jennifer J. Ryan; John Phipps; Douglas A. Hanes; Emily Stack; Janet K. Jansson; Thomas O. Metz; Jan Frederik Stevens; Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

doi:10.1186/s13063-020-04769-2

Back

Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial

Journal article

Open access

Peer reviewed

Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial

Ryan Bradley, Blake O. Langley, Jennifer J. Ryan, John Phipps, Douglas A. Hanes, Emily Stack, Janet K. Jansson, Thomas O. Metz, Jan Frederik Stevens and Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

Trials, Vol.21, pp.1-14

07/10/2020

DOI: https://doi.org/10.1186/s13063-020-04769-2

PMID: 33028396

Files and links (2)

pdf

Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial1.48 MBDownload View

Published (Version of record)CC BY V4.0, Open Access

url

Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trialView

Published (Version of record)CC BY V4.0, Open

Metrics

36 File views/ downloads

16 Record Views

11 Times Cited - Web of Science

See more details

UN Sustainable Development Goals (SDGs)

This output has contributed to the advancement of the following goals:

Source: InCites

Abstract

Life Sciences & Biomedicine

Medicine, Research & Experimental

Research & Experimental Medicine

Science & Technology

RCT

Human

Safety

Microbiome

Xanthohumol

Inflammation

Background: Natural products may provide a source for the discovery and development of adjunctive pharmacological interventions to modulate the inflammatory pathways contributing to chronic disease. Xanthohumol, a flavonoid from the hops plant (Humulus lupulus), has antioxidant and anti-inflammatory properties and may act as a prebiotic to the intestinal microbiota. Xanthohumol is not currently approved as a drug by the US Food and Drug Administration (FDA), but is available as a dietary supplement and ingredient in medical foods. To formally test the safety of xanthohumol, a phase I clinical trial ("XMaS") was designed and approved under an Investigational New Drug application to the US FDA. The main objective is to examine the clinical safety and subjective tolerability of xanthohumol in healthy adults compared to placebo. Additional aims are to monitor biomarkers related to inflammation, gut permeability, bile acid metabolism, routes, and in vivo products of xanthohumol metabolism, and to evaluate xanthohumol's impact on gut microbial composition. Methods: The safety and tolerability of xanthohumol in healthy adults will be evaluated in a triple-masked, randomized, placebo-controlled trial. Participants will be randomized to either 24mg/day of xanthohumol or placebo for 8 weeks. Blood cell counts, hepatic and renal function tests, electrolytes, and self-reported health-related quality of life measures will be collected every 2 weeks. Participants will be queried for adverse events throughout the trial. Xanthohumol metabolites in blood, urine, and stool will be measured. Biomarkers to be evaluated include plasma tumor necrosis factor-alpha, various interleukins, soluble CD14, lipopolysaccharide-binding protein, fecal calprotectin, and bile acids to assess impact on inflammatory and gut permeability-related mechanisms in vivo. Stool samples will be analyzed to determine effects on the gut microbiome. Discussion: This phase I clinical trial of xanthohumol will assess safety and tolerability in healthy adults, collect extensive biomarker data for assessment of potential mechanism(s), and provide comparison data necessary for future phase II trials in chronic disease(s). The design and robustness of the planned safety and mechanistic evaluations planned provide a model for drug discovery pursuits from natural products. Trial registration: ClinicalTrials.gov NCT03735420. Registered on November 8, 2018

Details

Title: Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial
Creators: Ryan Bradley - National University of Natural Medicine
Blake O. Langley - National University of Natural Medicine
Jennifer J. Ryan - National University of Natural Medicine
John Phipps - National University of Natural Medicine
Douglas A. Hanes - National University of Natural Medicine
Emily Stack - National University of Natural Medicine
Janet K. Jansson - Pacific Northwest National Laboratory
Thomas O. Metz - Pacific Northwest National Laboratory
Jan Frederik Stevens - Oregon State University
Pacific Northwest National Lab. (PNNL), Richland, WA (United States)
Publication Details: Trials, Vol.21, pp.1-14
Publisher: Springer Nature
Number of pages: 14
Grant note: R01 AT010271-02S1 / NCCIH R01 AT010271-02 / National Centers of Complimentary and Integrative Health
Identifiers: 991013035756802368
Academic Unit: National Centre for Naturopathic Medicine
Language: English
Resource Type: Journal article

Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial

Files and links (2)

Metrics

UN Sustainable Development Goals (SDGs)

Abstract

Details

Southern Cross University Social media