Xanthohumol Metabolism and Signature
Condition: Healthy
Intervention: Xanthohumol; Placebo oral capsule
Intervention description: 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.; 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.
Intervention MeSH terms: Xanthohumol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, 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.
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: xanthohumol; gut microbiome; inflammation

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.
    

Eligibility criteria:

        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