Xanthohumol Metabolism and Signature (XMaS) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Xanthohumol
Participants will receive 24 mg of 98% pure xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.
干预措施: Xanthohumol (Drug)
Placebo oral capsule
Participants will receive vehicle (rice protein) by mouth once daily with the first daily meal.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Incidence of Intervention-attributable Adverse Events [Safety and Tolerability]
时间窗: 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.
Change in Plasma Inflammatory Markers
时间窗: 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
次要结局
- Alanine Aminotransferase (ALT)(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Bile Acids(Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Estimated Glomerular Filtration Rate(2 weeks, 4 weeks, 6 weeks, and 8 weeks)
- Aspartate Aminotransferase (AST)(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Change in Levels of Metabolic Byproducts of Xanthohumol: Plasma and Urine(Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Gut Inflammation(Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Mean Corpuscular Volume(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Change in Levels of Metabolic Byproducts of Xanthohumol: Stool(Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Complete Blood Count Abnormals(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Total Red Blood Cell Count(Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Mean Corpuscular Hemoglobin(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Gamma-Glutamyl Transferase (GGT)(Baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks)
- Hematocrit(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Blood Urea Nitrogen to Creatinine Ratio(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Total White Blood Cell Count(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
- Platelet Count(2 weeks, 4 weeks, 6 weeks, and 8 weeks.)
研究者
Ryan Bradley
Director, Helfgott Research Institute
National University of Natural Medicine