- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735420
Xanthohumol Metabolism and Signature (XMaS)
Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97201
- Helfgott Research Institute National University of Natural Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
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)
- Currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 30 days)
- Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 30 days)
- Initiation of or changes to supplements or medications within 30 days prior to screening
- Initiation of or changes to an exercise regimen within 30 days prior to screening
- Initiation of or changes to a food plan within 30 days prior to screening
- Current involvement or within 30 days prior to screening of a significant diet or weight loss program, such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs, or very low-calorie liquid diet programs (such as optifast, medifast, and/or HMR)
- Hospitalization (for any reason other than an elective medical procedure) within 3 months prior to screening
- Gastrointestinal surgery within 3 months prior to screening
- Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis).
- Engaging in vigorous exercise more than 6 hours per week.
- Women who are lactating, pregnant or planning pregnancy within the next four months
- Typical intake of more than 2 alcohol-containing beverages per day, more than 14 per week, or more than 4 in any single day within the past 28 days
- Use of recreational drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 30 days of screening
- Currently participating in another interventional research study or participated in another interventional study within 30 days of screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Xanthohumol
Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.
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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.
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Placebo Comparator: Placebo oral capsule
Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plasma Inflammatory Markers
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Circulating pro-inflammatory cytokine concentrations (tumor necrosis factor (TNF)-α, interleukin (IL)-1 beta, IL-6, IL-8, IL-10, and IL-12p70), will be measured simultaneously with a flow cytometry-based multiplex assay.
The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
Reported as: New onset "FDA serious" adverse events (Grade 1); New onset "moderate" adverse events (Grade 2).
The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; weeks 2, 4, 6, and 8 reported.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry.
Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN).
The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Change in Levels of Metabolic Byproducts of Xanthohumol: Stool
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Xanthohumol and xanthohumol metabolites in blood, urine and stool, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry.
Metabolites include 6-prenylnaringenin (6-PN), 8-prenylnaringenin (8-PN), dihydroxanthohumol (DXN), desmethyldihydroxanthohumol (DDXN), isoxanthohumol (IXN), and xanthohumol (XN).
The measures were assessed at Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks; baseline, weeks 2, 4, 6, and 8 reported for urine and plasma.
As stool metabolites have not yet been analyzed, data will be released upon assessment.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Bile Acids
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Bile acid concentrations in blood and feces, will be measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry, and expressed as mean change over time from baseline.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Gut Inflammation
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Fecal calprotectin, a protein associated with gut inflammation and irritable gut syndrome, will be measured by enzyme-linked immunosorbent assay, and expressed as mean change over time from baseline.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Aspartate Aminotransferase (AST)
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity.
Reported as mean change from baseline.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Alanine Aminotransferase (ALT)
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity.
Reported as mean change from baseline.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Gamma-Glutamyl Transferase (GGT)
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
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Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity.
Reported as mean change from baseline.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
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Estimated Glomerular Filtration Rate
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
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Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice.
Reported as mean change from baseline.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks
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Blood Urea Nitrogen to Creatinine Ratio
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Blood urea nitrogen (BUN) : creatinine (Cr) is a ratio of serum concentrations of two compounds associated with renal function.
Reported as mean change from baseline.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Complete Blood Count Abnormals
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of the various subtypes of blood cells (i.e., red blood cells, white blood cells, and platelets), plus indices including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), and hematocrit.
Reported as: % abnormal (i.e., number of participants with an abnormal value compared to the number of participants in the group) and % new abnormals if abnormal counts were noted.
Abnormality is assessed according to standards for age and sex measurements under Quest Diagnostics criteria.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Total Red Blood Cell Count
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of total red blood cell count.
Reported as mean change from baseline.
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Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Total White Blood Cell Count
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of total white blood cell count.
Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Platelet Count
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of platelet count.
Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Mean Corpuscular Volume
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of mean corpuscular volume (MCV).
Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Mean Corpuscular Hemoglobin
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of mean corpuscular hemoglobin (MCH).
Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Hematocrit
Time Frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Enumeration of hematocrit.
Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
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2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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Collaborators and Investigators
Investigators
- Principal Investigator: Ryan Bradley, ND, MPH, National University of Natural Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RB9718
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
We will use the University of California San Diego (UCSD) Metabolomics Workbench for sharing metabolomics datasets and results (including raw data matrices, platform information, and associated metadata).
For activity-based proteomics data, we will use PRIDE or the MassIVE data repository at UCSD.
Nucleic acid sequence data will be submitted to the National Center for Biotechnology Information (NCBI) Short Read Archive.
Gene expression data will be submitted to Gene expression Omnibus at NCBI. Microbiome metadata will be deposited into database of Genotypes and Phenotypes.
Metagenomic nucleic acid sequence data will additionally be deposited in Metagenomic Rapid Annotations using Subsystems Technology (MG-RAST) at Argonne National Laboratory, along with associated metadata.
Microbiome summary files (e.g., tables cataloging: sample metadata, taxon or protein family abundances across samples) publicly available through github.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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