HealthyPhase 1XMaSNCT03735420
Xanthohumol Metabolism and Signature
A Phase 1 study testing Xanthohumol in people with Healthy, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Xanthohumol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Helfgott Research Institute National University of Natural Medicine
Portland, Oregon, 97201
About this study
Official title: Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults
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.
Read the 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
- Being tested
- Xanthohumol, Placebo oral capsule
- Keywords
- xanthohumol, gut microbiome, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XanthohumolDrug
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.
Placebo oral capsuleDrug
Also called Vehicle
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.
| Study group | Role | What they receive |
|---|---|---|
| Xanthohumol | Experimental | Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. Receives: Drug: Xanthohumol |
| Placebo oral capsule | Placebo comparator | Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Inflammatory Markers
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
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Secondary outcomes (16)
Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Change in Levels of Metabolic Byproducts of Xanthohumol: Stool
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Bile Acids
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Gut Inflammation
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Aspartate Aminotransferase (AST)
Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Alanine Aminotransferase (ALT)
Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Gamma-Glutamyl Transferase (GGT)
Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Estimated Glomerular Filtration Rate
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Blood Urea Nitrogen to Creatinine Ratio
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.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Complete Blood Count Abnormals
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.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Total Red Blood Cell Count
Enumeration of total red blood cell count. Reported as mean change from baseline.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Total White Blood Cell Count
Enumeration of total white blood cell count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Platelet Count
Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Mean Corpuscular Volume
Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Mean Corpuscular Hemoglobin
Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Hematocrit
Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Measured: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start12 Aug 2019
- Primary completion7 May 2020
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon State University, Pacific Northwest National Laboratory
- Responsible party
- Principal investigator, Ryan Bradley, National University of Natural Medicine
- Investigators
- Ryan Bradley, ND, MPH, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735420
- Sponsor's protocol ID
- RB9718
- Acronym
- XMaS
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2018
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Jamieson PE, Smart EB, Bouranis JA, Choi J, Danczak RE, Wong CP, Paraiso IL, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Gut enterotype-dependent modulation of gut microbiota and their metabolism in response to xanthohumol supplementation in healthy adults. Gut Microbes. 2024 Jan-Dec;16(1):2315633. doi: 10.1080/19490976.2024.2315633. Epub 2024 Feb 15.
PubMed 38358253Bradley R, Langley BO, Ryan JJ, Phipps J, Hanes DA, Stack E, Jansson JK, Metz TO, Stevens JF. Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial. Trials. 2020 Oct 7;21(1):835. doi: 10.1186/s13063-020-04769-2.
PubMed 33028396
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults
- ClinicalTrials.gov ID
- NCT03735420
- Acronym / sponsor ID
- XMaS / RB9718
- Conditions
- Healthy
- Keywords
- xanthohumol, gut microbiome, inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Oregon State University, Pacific Northwest National Laboratory
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.
| Arm | Type | Receives |
|---|---|---|
| Xanthohumol | Experimental | Drug: XanthohumolParticipants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal. |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleParticipants will receive vehicle (rice protein) by mouth once daily with the first daily meal. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XanthohumolThe 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 | Xanthohumol |
| Placebo oral capsuleAlso: VehicleThe placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal. | Drug | Placebo oral capsule |
Primary outcome
Change in Plasma Inflammatory Markers
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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
Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
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.
16 secondary outcomes
Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Change in Levels of Metabolic Byproducts of Xanthohumol: Stool
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Bile Acids
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Gut Inflammation
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Aspartate Aminotransferase (AST)
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Alanine Aminotransferase (ALT)
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Gamma-Glutamyl Transferase (GGT)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Estimated Glomerular Filtration Rate
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Blood Urea Nitrogen to Creatinine Ratio
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Complete Blood Count Abnormals
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Total Red Blood Cell Count
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Total White Blood Cell Count
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Platelet Count
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Mean Corpuscular Volume
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Mean Corpuscular Hemoglobin
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Hematocrit
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38358253Jamieson PE, Smart EB, Bouranis JA, Choi J, Danczak RE, Wong CP, Paraiso IL, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Gut enterotype-dependent modulation of gut microbiota and their metabolism in response to xanthohumol supplementation in healthy adults. Gut Microbes. 2024 Jan-Dec;16(1):2315633. doi: 10.1080/19490976.2024.2315633. Epub 2024 Feb 15.
- Derived from this study: PubMed 33028396Bradley R, Langley BO, Ryan JJ, Phipps J, Hanes DA, Stack E, Jansson JK, Metz TO, Stevens JF. Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial. Trials. 2020 Oct 7;21(1):835. doi: 10.1186/s13063-020-04769-2.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Bradley, ND, MPH principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xanthohumol in people with Healthy, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Inflammatory Markers (time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03735420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.