Healthy
Conditions
Keywords
xanthohumol, gut microbiome, inflammation
Brief 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.
Interventions
DRUGXanthohumol
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.
DRUGPlacebo 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
Oregon State University
Pacific Northwest National Laboratory
National University of Natural Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomization will occur in up to 8 blocks of 4 based on biological sex. Initial randomization series will be generated using readily available random sequence generators designed to do so. A series of sequential envelopes will be generated, each containing the allocation for one participant. Envelopes will be opaque and signed across the seal. The randomization code will be kept in a sealed envelope with a signature across the label and dated the day of creation. Study product and comparator (placebo) will be compounded and placed in identical opaque capsules outside the institution.
Intervention model description
Participants will be randomized to receive either encapsulated xanthohumol in a rice protein vehicle, or an identical capsule containing vehicle alone.
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Inflammatory Markers | 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] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bile Acids | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | 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. |
| Gut Inflammation | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | 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. |
| Aspartate Aminotransferase (AST) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. |
| Alanine Aminotransferase (ALT) | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. |
| Gamma-Glutamyl Transferase (GGT) | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks | Gamma-glutamyl transferase is an enzyme that is often measured in blood as an indication of liver toxicity. Reported as mean change from baseline. |
| Estimated Glomerular Filtration Rate | 2 weeks, 4 weeks, 6 weeks, and 8 weeks | Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline. |
| Blood Urea Nitrogen to Creatinine Ratio | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | 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. |
| Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | 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. |
| Total Red Blood Cell Count | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Enumeration of total red blood cell count. Reported as mean change from baseline. |
| Total White Blood Cell Count | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Enumeration of total white blood cell count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. |
| Platelet Count | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. |
| Mean Corpuscular Volume | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. |
| Mean Corpuscular Hemoglobin | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. |
| Hematocrit | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8. |
| Complete Blood Count Abnormals | 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | 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. |
| Change in Levels of Metabolic Byproducts of Xanthohumol: Stool | Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xanthohumol Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.
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. | 16 |
| Placebo Oral Capsule Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.
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. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Placebo Oral Capsule | Total | Xanthohumol |
|---|---|---|---|
| Age, Continuous | 33.14 years STANDARD_DEVIATION 5.36 | 30.97 years STANDARD_DEVIATION 6.22 | 29.06 years STANDARD_DEVIATION 6.45 |
| Body mass index | 23.30 kilogram per meters-squared (kg/m2) STANDARD_DEVIATION 2.57 | 23.36 kilogram per meters-squared (kg/m2) STANDARD_DEVIATION 2.36 | 23.41 kilogram per meters-squared (kg/m2) STANDARD_DEVIATION 2.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 27 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Heart rate | 61.07 beats per minute (bpm) STANDARD_DEVIATION 8.3 | 62.90 beats per minute (bpm) STANDARD_DEVIATION 10.28 | 64.50 beats per minute (bpm) STANDARD_DEVIATION 11.78 |
| Height | 1.73 meters STANDARD_DEVIATION 0.11 | 1.73 meters STANDARD_DEVIATION 0.12 | 1.73 meters STANDARD_DEVIATION 0.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 28 Participants | 16 Participants |
| Region of Enrollment United States | 14 participants | 30 participants | 16 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
| Weight | 70.60 kilograms STANDARD_DEVIATION 14.59 | 70.18 kilograms STANDARD_DEVIATION 12.28 | 69.82 kilograms STANDARD_DEVIATION 10.33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 14 / 16 | 12 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 6: IL-6 | -51 picogram per milliliter (pg/mL) | Standard Deviation 251 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 4: IL-1b | 172 picogram per milliliter (pg/mL) | Standard Deviation 677 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 6: IL-1b | 2368 picogram per milliliter (pg/mL) | Standard Deviation 7689 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 8: IL-1b | -133 picogram per milliliter (pg/mL) | Standard Deviation 328 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 2: Interleukin 6 (IL-6) | -54 picogram per milliliter (pg/mL) | Standard Deviation 252 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 4: IL-6 | -79 picogram per milliliter (pg/mL) | Standard Deviation 263 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 2: Interleukin 1-beta (IL-1b) | 220 picogram per milliliter (pg/mL) | Standard Deviation 358 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 8: IL-6 | 3565 picogram per milliliter (pg/mL) | Standard Deviation 12594 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 2: Interleukin 8 (IL-8) | 1796 picogram per milliliter (pg/mL) | Standard Deviation 6380 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 4: IL-8 | -7 picogram per milliliter (pg/mL) | Standard Deviation 352 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 6: IL-8 | 276 picogram per milliliter (pg/mL) | Standard Deviation 840 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 8: IL-8 | 2639 picogram per milliliter (pg/mL) | Standard Deviation 6116 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 2: Interleukin 10 (IL-10) | 76 picogram per milliliter (pg/mL) | Standard Deviation 273 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 4: IL-10 | 10 picogram per milliliter (pg/mL) | Standard Deviation 44 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 6: IL-10 | -2 picogram per milliliter (pg/mL) | Standard Deviation 17 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 8: IL-10 | -3 picogram per milliliter (pg/mL) | Standard Deviation 13 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 2: Interleukin 12p70 (IL-12p70) | 2 picogram per milliliter (pg/mL) | Standard Deviation 9 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 4: IL-12p70 | 3 picogram per milliliter (pg/mL) | Standard Deviation 12 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 6: IL-12p70 | -2 picogram per milliliter (pg/mL) | Standard Deviation 12 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 8: IL-12p70 | 1 picogram per milliliter (pg/mL) | Standard Deviation 9 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 2: Tumor Necrosis Factor Alpha (TNFa) | 2 picogram per milliliter (pg/mL) | Standard Deviation 9 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 4: TNFa | -3 picogram per milliliter (pg/mL) | Standard Deviation 9 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 6: TNFa | -4 picogram per milliliter (pg/mL) | Standard Deviation 10 |
| Placebo Oral Capsule | Change in Plasma Inflammatory Markers | Week 8: TNFa | -1 picogram per milliliter (pg/mL) | Standard Deviation 8 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 6: TNFa | -23 picogram per milliliter (pg/mL) | Standard Deviation 102 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 2: Interleukin 1-beta (IL-1b) | -2463 picogram per milliliter (pg/mL) | Standard Deviation 12960 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 2: Interleukin 10 (IL-10) | -46 picogram per milliliter (pg/mL) | Standard Deviation 180 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 4: IL-1b | -3153 picogram per milliliter (pg/mL) | Standard Deviation 12490 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 6: IL-12p70 | -14 picogram per milliliter (pg/mL) | Standard Deviation 46 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 6: IL-1b | -620 picogram per milliliter (pg/mL) | Standard Deviation 16359 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 4: IL-10 | -34 picogram per milliliter (pg/mL) | Standard Deviation 150 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 8: IL-1b | -3624 picogram per milliliter (pg/mL) | Standard Deviation 12306 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 4: TNFa | -28 picogram per milliliter (pg/mL) | Standard Deviation 100 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 2: Interleukin 6 (IL-6) | -784 picogram per milliliter (pg/mL) | Standard Deviation 2795 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 6: IL-10 | -49 picogram per milliliter (pg/mL) | Standard Deviation 177 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 4: IL-6 | -684 picogram per milliliter (pg/mL) | Standard Deviation 2552 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 8: IL-12p70 | 0 picogram per milliliter (pg/mL) | Standard Deviation 55 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 6: IL-6 | -764 picogram per milliliter (pg/mL) | Standard Deviation 2802 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 8: IL-10 | -43 picogram per milliliter (pg/mL) | Standard Deviation 171 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 8: IL-6 | -784 picogram per milliliter (pg/mL) | Standard Deviation 2792 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 8: TNFa | -25 picogram per milliliter (pg/mL) | Standard Deviation 100 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 2: Interleukin 8 (IL-8) | -5914 picogram per milliliter (pg/mL) | Standard Deviation 22847 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 2: Interleukin 12p70 (IL-12p70) | 25 picogram per milliliter (pg/mL) | Standard Deviation 154 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 4: IL-8 | 7669 picogram per milliliter (pg/mL) | Standard Deviation 62489 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 2: Tumor Necrosis Factor Alpha (TNFa) | -8 picogram per milliliter (pg/mL) | Standard Deviation 124 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 6: IL-8 | -6955 picogram per milliliter (pg/mL) | Standard Deviation 25976 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 4: IL-12p70 | -7 picogram per milliliter (pg/mL) | Standard Deviation 52 |
| Xanthohumol | Change in Plasma Inflammatory Markers | Week 8: IL-8 | -6882 picogram per milliliter (pg/mL) | Standard Deviation 25878 |
Primary
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 2 Grade 1 | 12 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 2 Grade 2 | 2 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 4 Grade 1 | 18 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 4 Grade 2 | 0 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 6 Grade 1 | 18 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 6 Grade 2 | 8 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 8 Grade 1 | 5 Adverse events |
| Placebo Oral Capsule | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 8 Grade 2 | 2 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 8 Grade 2 | 2 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 2 Grade 1 | 9 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 6 Grade 1 | 11 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 2 Grade 2 | 2 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 8 Grade 1 | 0 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 4 Grade 1 | 9 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 6 Grade 2 | 2 Adverse events |
| Xanthohumol | Incidence of Intervention-attributable Adverse Events [Safety and Tolerability] | Week 4 Grade 2 | 3 Adverse events |
Secondary
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.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Alanine Aminotransferase (ALT) | Week 2 | 18.0 milligrams per decileter (mg/dL) | Standard Deviation 15.1 |
| Placebo Oral Capsule | Alanine Aminotransferase (ALT) | Week 4 | 16.1 milligrams per decileter (mg/dL) | Standard Deviation 7.5 |
| Placebo Oral Capsule | Alanine Aminotransferase (ALT) | Week 8 | 15.1 milligrams per decileter (mg/dL) | Standard Deviation 9.2 |
| Placebo Oral Capsule | Alanine Aminotransferase (ALT) | Week 6 | 16.4 milligrams per decileter (mg/dL) | Standard Deviation 7.5 |
| Xanthohumol | Alanine Aminotransferase (ALT) | Week 8 | 12.9 milligrams per decileter (mg/dL) | Standard Deviation 2.84 |
| Xanthohumol | Alanine Aminotransferase (ALT) | Week 2 | 14.9 milligrams per decileter (mg/dL) | Standard Deviation 3.8 |
| Xanthohumol | Alanine Aminotransferase (ALT) | Week 4 | 14.0 milligrams per decileter (mg/dL) | Standard Deviation 3.81 |
| Xanthohumol | Alanine Aminotransferase (ALT) | Week 6 | 15.4 milligrams per decileter (mg/dL) | Standard Deviation 5.11 |
Secondary
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.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Aspartate Aminotransferase (AST) | Week 2 | 22.9 milligrams per deciliter (mgdL) | Standard Deviation 13.5 |
| Placebo Oral Capsule | Aspartate Aminotransferase (AST) | Week 4 | 18.3 milligrams per deciliter (mgdL) | Standard Deviation 5.1 |
| Placebo Oral Capsule | Aspartate Aminotransferase (AST) | Week 6 | 21.1 milligrams per deciliter (mgdL) | Standard Deviation 8.9 |
| Placebo Oral Capsule | Aspartate Aminotransferase (AST) | Week 8 | 18.4 milligrams per deciliter (mgdL) | Standard Deviation 5.8 |
| Xanthohumol | Aspartate Aminotransferase (AST) | Week 8 | 15.5 milligrams per deciliter (mgdL) | Standard Deviation 2.6 |
| Xanthohumol | Aspartate Aminotransferase (AST) | Week 2 | 15.4 milligrams per deciliter (mgdL) | Standard Deviation 2.6 |
| Xanthohumol | Aspartate Aminotransferase (AST) | Week 6 | 16.4 milligrams per deciliter (mgdL) | Standard Deviation 3.2 |
| Xanthohumol | Aspartate Aminotransferase (AST) | Week 4 | 15.3 milligrams per deciliter (mgdL) | Standard Deviation 3.01 |
Secondary
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Secondary
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.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Blood Urea Nitrogen to Creatinine Ratio | Week 2 | 16.4 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 29 |
| Placebo Oral Capsule | Blood Urea Nitrogen to Creatinine Ratio | Week 6 | 14.8 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 41.4 |
| Placebo Oral Capsule | Blood Urea Nitrogen to Creatinine Ratio | Week 4 | 15.2 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 31.5 |
| Placebo Oral Capsule | Blood Urea Nitrogen to Creatinine Ratio | Closeout | 14.5 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 30.9 |
| Placebo Oral Capsule | Blood Urea Nitrogen to Creatinine Ratio | Baseline | 15.6 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 40.8 |
| Xanthohumol | Blood Urea Nitrogen to Creatinine Ratio | Closeout | 14.7 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 26.3 |
| Xanthohumol | Blood Urea Nitrogen to Creatinine Ratio | Baseline | 14.5 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 25.2 |
| Xanthohumol | Blood Urea Nitrogen to Creatinine Ratio | Week 2 | 15.5 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 32.4 |
| Xanthohumol | Blood Urea Nitrogen to Creatinine Ratio | Week 4 | 15.3 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 26.4 |
| Xanthohumol | Blood Urea Nitrogen to Creatinine Ratio | Week 6 | 14.5 Ratio of BUN (mg/dL) to Cr (mg/dL) | Standard Deviation 23.4 |
Secondary
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-Prenylnaringenin (6PN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-PN: Week 6 | 7.196 nanograms per millileter (ng/mL) | Standard Deviation 14.662 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 2 | .041 nanograms per millileter (ng/mL) | Standard Deviation 0.148 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 4 | .036 nanograms per millileter (ng/mL) | Standard Deviation 0.131 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8- PN Week 8 | 4.725 nanograms per millileter (ng/mL) | Standard Deviation 7.769 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-Prenylnaringenin: Baseline | 1.302 nanograms per millileter (ng/mL) | Standard Deviation 3.034 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 2 | 1.503 nanograms per millileter (ng/mL) | Standard Deviation 3.34 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-Prenylnaringenin (8-PN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 4 | .840 nanograms per millileter (ng/mL) | Standard Deviation 3.144 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 8 | .071 nanograms per millileter (ng/mL) | Standard Deviation 0.257 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 6 | 1.001 nanograms per millileter (ng/mL) | Standard Deviation 2.563 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Dihydroxanthohumol (DXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 8 | 1.302 nanograms per millileter (ng/mL) | Standard Deviation 3.034 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Isoxanthohumol (IXN): Baseline | 2.237 nanograms per millileter (ng/mL) | Standard Deviation 4.364 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Dihydroxanthohumol (DXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 2 | .968 nanograms per millileter (ng/mL) | Standard Deviation 3.622 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 2 | 94.120 nanograms per millileter (ng/mL) | Standard Deviation 82.5 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 2 | .562 nanograms per millileter (ng/mL) | Standard Deviation 0.542 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 4 | 103.920 nanograms per millileter (ng/mL) | Standard Deviation 75.201 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-PN: Week 2 | 6.811 nanograms per millileter (ng/mL) | Standard Deviation 12.029 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Desmethyldihydroxanthohumol (DDXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 6 | 66.628 nanograms per millileter (ng/mL) | Standard Deviation 41.899 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 4 | .561 nanograms per millileter (ng/mL) | Standard Deviation 0.522 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 8 | 95.756 nanograms per millileter (ng/mL) | Standard Deviation 83.275 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 4 | .591 nanograms per millileter (ng/mL) | Standard Deviation 2.132 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Xanthohumol (XN) Baseline | 1.952 nanograms per millileter (ng/mL) | Standard Deviation 13.967 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Isoxanthohumol (IXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 6 | .410 nanograms per millileter (ng/mL) | Standard Deviation 0.325 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 2 | 7.864 nanograms per millileter (ng/mL) | Standard Deviation 4.135 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 2 | 21.280 nanograms per millileter (ng/mL) | Standard Deviation 12.112 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 4 | 6.999 nanograms per millileter (ng/mL) | Standard Deviation 3.514 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-PN: Week 4 | 6.588 nanograms per millileter (ng/mL) | Standard Deviation 0.84 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 6 | 6.140 nanograms per millileter (ng/mL) | Standard Deviation 3.565 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 4 | 14.908 nanograms per millileter (ng/mL) | Standard Deviation 8.667 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 8 | 8.174 nanograms per millileter (ng/mL) | Standard Deviation 3.794 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 8 | 2.043 nanograms per millileter (ng/mL) | Standard Deviation 4.702 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Xanthohumol (XN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 6 | 19.979 nanograms per millileter (ng/mL) | Standard Deviation 12.242 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 2 | 7.156 nanograms per millileter (ng/mL) | Standard Deviation 3.888 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 4 | 6.784 nanograms per millileter (ng/mL) | Standard Deviation 3.497 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 8 | 19.952 nanograms per millileter (ng/mL) | Standard Deviation 13.967 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 6 | 5.810 nanograms per millileter (ng/mL) | Standard Deviation 3.153 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Desmethyldihydroxanthohumol (DDXN): Baseline | .042 nanograms per millileter (ng/mL) | Standard Deviation 0.152 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 8 | 5.796 nanograms per millileter (ng/mL) | Standard Deviation 3.188 |
| Placebo Oral Capsule | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-Prenylnaringenin (6-PN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-Prenylnaringenin (6-PN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 6-PN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-Prenylnaringenin (8-PN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-PN: Week 2 | 1.412 nanograms per millileter (ng/mL) | Standard Deviation 3.877 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-PN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8-PN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary 8- PN Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Dihydroxanthohumol (DXN): Baseline | .086 nanograms per millileter (ng/mL) | Standard Deviation 0.312 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DXN: Week 8 | .016 nanograms per millileter (ng/mL) | Standard Deviation 0.059 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Desmethyldihydroxanthohumol (DDXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary DDXN: Week 8 | .023 nanograms per millileter (ng/mL) | Standard Deviation 0.083 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Isoxanthohumol (IXN): Baseline | .299 nanograms per millileter (ng/mL) | Standard Deviation 1.08 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 2 | 2.121 nanograms per millileter (ng/mL) | Standard Deviation 4.001 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 4 | .494 nanograms per millileter (ng/mL) | Standard Deviation 1.782 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 6 | .281 nanograms per millileter (ng/mL) | Standard Deviation 1.012 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary IXN: Week 8 | .484 nanograms per millileter (ng/mL) | Standard Deviation 1.745 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary Xanthohumol (XN) Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 2 | 4.666 nanograms per millileter (ng/mL) | Standard Deviation 16.44 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 4 | .124 nanograms per millileter (ng/mL) | Standard Deviation 0.448 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Urinary XN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-Prenylnaringenin (6PN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 6-PN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-Prenylnaringenin: Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma 8-PN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Dihydroxanthohumol (DXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 6 | 7.288 nanograms per millileter (ng/mL) | Standard Deviation 25.245 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DXN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Desmethyldihydroxanthohumol (DDXN): Baseline | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma DDXN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Isoxanthohumol (IXN): Baseline | .275 nanograms per millileter (ng/mL) | Standard Deviation 0.992 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 2 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 6 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma IXN: Week 8 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma Xanthohumol (XN): Baseline | .365 nanograms per millileter (ng/mL) | Standard Deviation 0.974 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 2 | 1.325 nanograms per millileter (ng/mL) | Standard Deviation 3.424 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 4 | 0 nanograms per millileter (ng/mL) | Standard Deviation 0 |
| Xanthohumol | Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine | Plasma XN: Week 6 | .822 nanograms per millileter (ng/mL) | Standard Deviation 2.304 |
Secondary
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
Secondary
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.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 6) : number of abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 2) : number of abnormals | 0 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 6) : number of new abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 8) : number of abnormal | 0 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 8) : number of abnormals | 0 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 2) : number of new abnormals | 0 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 8) : %new abnormals | 0 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Mean Corpuscular Hemoglobin (Week 8) : number of abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 2) : number of abnormals | 3 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 4) : number of abnormals | 2 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 2) : number of new abnormals | 3 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 4) : number of new abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 4) : number of abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Mean Corpuscular Hemoglobin (Week 8) : number of new abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 6) : number of abnormals | 2 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 4) : number of new abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 6) : number of new abnormals | 2 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Hemoglobin (Week 4) : number of new abnormals | 2 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 8) : number of abnormal | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 8) : number of new abnormals | 0 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 8) : %new abnormals | 1 participants |
| Placebo Oral Capsule | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 4): number of abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 8) : %new abnormals | 0 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 4): number of abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 4) : number of new abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 8) : number of abnormal | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total Red Blood Cell Count (Week 8) : number of new abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Mean Corpuscular Hemoglobin (Week 8) : number of abnormals | 0 participants |
| Xanthohumol | Complete Blood Count Abnormals | Mean Corpuscular Hemoglobin (Week 8) : number of new abnormals | 0 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 2) : number of abnormals | 2 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 2) : number of new abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 4) : number of abnormals | 2 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 4) : number of new abnormals | 0 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 4) : number of new abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 6) : number of abnormals | 2 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 6) : number of new abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 8) : number of abnormals | 3 participants |
| Xanthohumol | Complete Blood Count Abnormals | Hemoglobin (Week 8) : %new abnormals | 2 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 2) : number of abnormals | 2 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 2) : number of new abnormals | 0 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 4) : number of abnormals | 2 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 6) : number of abnormals | 3 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 6) : number of new abnormals | 1 participants |
| Xanthohumol | Complete Blood Count Abnormals | Total White Blood Cell Count (Week 8) : number of abnormal | 1 participants |
Secondary
Estimated Glomerular Filtration Rate
Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. Reported as mean change from baseline.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Estimated Glomerular Filtration Rate | Week 2 | 108.7 millileters per minute (mL/min) | Standard Deviation 11.3 |
| Placebo Oral Capsule | Estimated Glomerular Filtration Rate | Week 4 | 110.6 millileters per minute (mL/min) | Standard Deviation 11.4 |
| Placebo Oral Capsule | Estimated Glomerular Filtration Rate | Week 6 | 109.2 millileters per minute (mL/min) | Standard Deviation 10.2 |
| Placebo Oral Capsule | Estimated Glomerular Filtration Rate | Week 8 | 108.4 millileters per minute (mL/min) | Standard Deviation 11.9 |
| Xanthohumol | Estimated Glomerular Filtration Rate | Week 8 | 111.8 millileters per minute (mL/min) | Standard Deviation 13.8 |
| Xanthohumol | Estimated Glomerular Filtration Rate | Week 2 | 112.0 millileters per minute (mL/min) | Standard Deviation 12.9 |
| Xanthohumol | Estimated Glomerular Filtration Rate | Week 6 | 111.4 millileters per minute (mL/min) | Standard Deviation 11.2 |
| Xanthohumol | Estimated Glomerular Filtration Rate | Week 4 | 111.8 millileters per minute (mL/min) | Standard Deviation 12.1 |
Secondary
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Gamma-Glutamyl Transferase (GGT) | Week 2 | 12.1 milligrams per decileter (mg/dL) | Standard Deviation 3.4 |
| Placebo Oral Capsule | Gamma-Glutamyl Transferase (GGT) | Week 4 | 12.3 milligrams per decileter (mg/dL) | Standard Deviation 4.3 |
| Placebo Oral Capsule | Gamma-Glutamyl Transferase (GGT) | Week 6 | 12.9 milligrams per decileter (mg/dL) | Standard Deviation 4.74 |
| Placebo Oral Capsule | Gamma-Glutamyl Transferase (GGT) | Week 8 | 12.1 milligrams per decileter (mg/dL) | Standard Deviation 4.52 |
| Xanthohumol | Gamma-Glutamyl Transferase (GGT) | Week 8 | 11.8 milligrams per decileter (mg/dL) | Standard Deviation 5 |
| Xanthohumol | Gamma-Glutamyl Transferase (GGT) | Week 2 | 11.8 milligrams per decileter (mg/dL) | Standard Deviation 4.58 |
| Xanthohumol | Gamma-Glutamyl Transferase (GGT) | Week 6 | 12.3 milligrams per decileter (mg/dL) | Standard Deviation 6.92 |
| Xanthohumol | Gamma-Glutamyl Transferase (GGT) | Week 4 | 11.8 milligrams per decileter (mg/dL) | Standard Deviation 5.82 |
Secondary
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.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Gut Inflammation | Week 2 | 12.4 microgram per milligram (ug/mg) | Standard Deviation 1.5 |
| Placebo Oral Capsule | Gut Inflammation | Week 6 | 12.7 microgram per milligram (ug/mg) | Standard Deviation 2.5 |
| Placebo Oral Capsule | Gut Inflammation | Week 4 | 13.4 microgram per milligram (ug/mg) | Standard Deviation 3.9 |
| Placebo Oral Capsule | Gut Inflammation | Week 8 | 15.2 microgram per milligram (ug/mg) | Standard Deviation 10.3 |
| Placebo Oral Capsule | Gut Inflammation | Baseline | 12.8 microgram per milligram (ug/mg) | Standard Deviation 2.7 |
| Xanthohumol | Gut Inflammation | Week 8 | 13.2 microgram per milligram (ug/mg) | Standard Deviation 2.6 |
| Xanthohumol | Gut Inflammation | Baseline | 35.2 microgram per milligram (ug/mg) | Standard Deviation 76.7 |
| Xanthohumol | Gut Inflammation | Week 2 | 19.9 microgram per milligram (ug/mg) | Standard Deviation 21.8 |
| Xanthohumol | Gut Inflammation | Week 4 | 12.7 microgram per milligram (ug/mg) | Standard Deviation 2.5 |
| Xanthohumol | Gut Inflammation | Week 6 | 14.3 microgram per milligram (ug/mg) | Standard Deviation 5.4 |
Secondary
Hematocrit
Enumeration of hematocrit. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Hematocrit | Hematocrit (Week 2) | 0.77 percent (%) | Standard Deviation 1.92 |
| Placebo Oral Capsule | Hematocrit | Hematocrit (Week 4) | -0.20 percent (%) | Standard Deviation 1.56 |
| Placebo Oral Capsule | Hematocrit | Hematocrit (Week 6) | -0.32 percent (%) | Standard Deviation 1.6 |
| Placebo Oral Capsule | Hematocrit | Hematocrit (Week 8) | -0.03 percent (%) | Standard Deviation 2.16 |
| Xanthohumol | Hematocrit | Hematocrit (Week 8) | 0.44 percent (%) | Standard Deviation 2.27 |
| Xanthohumol | Hematocrit | Hematocrit (Week 2) | 0.48 percent (%) | Standard Deviation 1.49 |
| Xanthohumol | Hematocrit | Hematocrit (Week 6) | 0.57 percent (%) | Standard Deviation 2.11 |
| Xanthohumol | Hematocrit | Hematocrit (Week 4) | 0.23 percent (%) | Standard Deviation 2.18 |
Secondary
Mean Corpuscular Hemoglobin
Enumeration of mean corpuscular hemoglobin (MCH). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 2) | 0.05 picograms (pg) | Standard Deviation 0.35 |
| Placebo Oral Capsule | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 4) | 0.26 picograms (pg) | Standard Deviation 0.53 |
| Placebo Oral Capsule | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 6) | 0.29 picograms (pg) | Standard Deviation 0.42 |
| Placebo Oral Capsule | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 8) | 0.20 picograms (pg) | Standard Deviation 0.52 |
| Xanthohumol | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 8) | -0.23 picograms (pg) | Standard Deviation 0.87 |
| Xanthohumol | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 2) | -0.06 picograms (pg) | Standard Deviation 0.45 |
| Xanthohumol | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 6) | -0.13 picograms (pg) | Standard Deviation 0.76 |
| Xanthohumol | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin (Week 4) | -0.04 picograms (pg) | Standard Deviation 0.51 |
Secondary
Mean Corpuscular Volume
Enumeration of mean corpuscular volume (MCV). Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 2) | .14 femtoliter (fL) | Standard Deviation 0.76 |
| Placebo Oral Capsule | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 4) | .61 femtoliter (fL) | Standard Deviation 1.45 |
| Placebo Oral Capsule | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 6) | .04 femtoliter (fL) | Standard Deviation 1.47 |
| Placebo Oral Capsule | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 8) | .04 femtoliter (fL) | Standard Deviation 0.8 |
| Xanthohumol | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 8) | -0.63 femtoliter (fL) | Standard Deviation 1.88 |
| Xanthohumol | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 2) | .20 femtoliter (fL) | Standard Deviation 1.21 |
| Xanthohumol | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 6) | -0.25 femtoliter (fL) | Standard Deviation 1.56 |
| Xanthohumol | Mean Corpuscular Volume | Mean Corpuscular Volume (Week 4) | -0.27 femtoliter (fL) | Standard Deviation 1.54 |
Secondary
Platelet Count
Enumeration of platelet count. Results are reported as mean change from baseline at weeks 2, 4, 6, and 8.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Platelet Count | Platelet Count (Week 2) | 3.54 thousand cells per microliter (1000/uL) | Standard Deviation 24.05 |
| Placebo Oral Capsule | Platelet Count | Platelet Count (Week 4) | 3.46 thousand cells per microliter (1000/uL) | Standard Deviation 19.62 |
| Placebo Oral Capsule | Platelet Count | Platelet Count (Week 6) | 14.00 thousand cells per microliter (1000/uL) | Standard Deviation 32.01 |
| Placebo Oral Capsule | Platelet Count | Platelet Count (Week 8) | 10.46 thousand cells per microliter (1000/uL) | Standard Deviation 25.62 |
| Xanthohumol | Platelet Count | Platelet Count (Week 8) | 7.14 thousand cells per microliter (1000/uL) | Standard Deviation 20.47 |
| Xanthohumol | Platelet Count | Platelet Count (Week 2) | 2.60 thousand cells per microliter (1000/uL) | Standard Deviation 26.04 |
| Xanthohumol | Platelet Count | Platelet Count (Week 6) | 22.93 thousand cells per microliter (1000/uL) | Standard Deviation 41.9 |
| Xanthohumol | Platelet Count | Platelet Count (Week 4) | 0.07 thousand cells per microliter (1000/uL) | Standard Deviation 19.86 |
Secondary
Total Red Blood Cell Count
Enumeration of total red blood cell count. Reported as mean change from baseline.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 2) | .08 mean change from baseline | Standard Deviation 0.22 |
| Placebo Oral Capsule | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 4) | -.06 mean change from baseline | Standard Deviation 0.2 |
| Placebo Oral Capsule | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 6) | -.04 mean change from baseline | Standard Deviation 0.16 |
| Placebo Oral Capsule | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 8) | .00 mean change from baseline | Standard Deviation 0.23 |
| Xanthohumol | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 8) | .08 mean change from baseline | Standard Deviation 0.24 |
| Xanthohumol | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 2) | .04 mean change from baseline | Standard Deviation 0.15 |
| Xanthohumol | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 6) | .07 mean change from baseline | Standard Deviation 0.23 |
| Xanthohumol | Total Red Blood Cell Count | Total Red Blood Cell Count (Week 4) | .04 mean change from baseline | Standard Deviation 0.2 |
Secondary
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.
Time frame: 2 weeks, 4 weeks, 6 weeks, and 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Oral Capsule | Total White Blood Cell Count | Total White Blood Cell Count (Week 2) | -.05 thousand cells per microliter (1000/uL) | Standard Deviation 1 |
| Placebo Oral Capsule | Total White Blood Cell Count | Total White Blood Cell Count (Week 4) | -.05 thousand cells per microliter (1000/uL) | Standard Deviation 0.98 |
| Placebo Oral Capsule | Total White Blood Cell Count | Total White Blood Cell Count (Week 6) | .23 thousand cells per microliter (1000/uL) | Standard Deviation 1.17 |
| Placebo Oral Capsule | Total White Blood Cell Count | Total White Blood Cell Count (Week 8) | .21 thousand cells per microliter (1000/uL) | Standard Deviation 0.76 |
| Xanthohumol | Total White Blood Cell Count | Total White Blood Cell Count (Week 8) | -.24 thousand cells per microliter (1000/uL) | Standard Deviation 1.44 |
| Xanthohumol | Total White Blood Cell Count | Total White Blood Cell Count (Week 2) | -.59 thousand cells per microliter (1000/uL) | Standard Deviation 1.19 |
| Xanthohumol | Total White Blood Cell Count | Total White Blood Cell Count (Week 6) | -.24 thousand cells per microliter (1000/uL) | Standard Deviation 1.6 |
| Xanthohumol | Total White Blood Cell Count | Total White Blood Cell Count (Week 4) | -.09 thousand cells per microliter (1000/uL) | Standard Deviation 1.82 |