PLXCOM Quercetin | Screening Script QUERPK Quercetin Short Term Absorption Study "*" indicates required fields Short Term Absorption Study • Introduce yourself (name, role, and company) • Tell the potential participant you are calling following their expressed interest in one of our trials. RDC Clinical is a clinical research organisation within the industries of complementary medicines, dietary supplements, foods and cosmetics. RDC Clinical is working in collaboration with The University of Queensland to conduct this clinical trial. What is the trial This trial is a double-blind randomised controlled, cross-over study conducted in healthy participants aged 18 years and older. The study is testing the absorption of Quercetin and you will be required to take three doses for a total consumption of 800mg. This study aims to compare the absorption of a single dose of Berberine with and without absorption enhancing technology in healthy participants over a period of up to 9-hours. As this study is a cross-over study, you will be required to take a single dose the supplements being tested on 3 occasions, each separated by a 2 week washout period The study dates for this study are as follows: Group 1 Round 1 Thursday June 26th Day 1 : 7am to approximately 4pm Friday June 27th Day 2 : Approximately 15 minutes (between 7 and 9am) Round 2 Thursday July 10th Day 1 : 7am to approximately 4pm Friday July 11th Day 2 : Approximately 15 minutes (between 7 and 9am) Round 3 Thursday July 24th Day 1 : 7am to approximately 4pm Friday July 25th Day 2 : Approximately 15 minutes (between 7 and 9am) Group 2 Round 1 Thursday July 3rd Day 1 : 7am to approximately 4pm Friday July 4th Day 2 : Approximately 15 minutes (between 7 and 9am) Round 2 Thursday July 17th Day 1 : 7am to approximately 4pm Friday July 18th Day 2 : Approximately 15 minutes (between 7 and 9am) Round 3 Thursday July 31st Day 1 : 7am to approximately 4pm Friday August 1st Day 2 : Approximately 15 minutes (between 7 and 9am) Would you be available to attend one of these groups on these study dates? Your total involvement in this study will be approximately 6 weeks in total. You are required to attend 2 consecutive clinic visits for each supplement. For a total of 6 clinic visits over the 6 weeks. Each supplement dose will require you to attend 1 full in-clinic day of 9 hours and 1 follow-up clinic visit of up to 30 minutes. You will then be required to return to the study site 2 weeks later for a repeat of the study with the second supplement dose and again 2 weeks later for a repeat of the study with the third supplement dose. Therefore, your time involvement in this trial will be up to 28.5 hours in total over approximately 6 weeks. On each of the full day clinic visits, you will be required to arrive fasted, and have a cannula inserted into your arm. This will be used to take blood from you throughout the day to avoid having to repeatedly insert a needle. Have you had a cannula before? • If yes, move on • If no explain what it is and that it will stay in the arm On each of the follow-up visits, you do not need to be fasted, and will only have a single blood sample taken. Over the 6 weeks of the study, we will take approximately 200 mL of blood from you. This represents approximately 4% of your blood volume and will not compromise your health. If you complete the study, you will receive a $400 payment. Are you still interested in proceeding with the trial? • If no, thank them for their time and wish them well. • If yes, proceed to the screening criteria. Now I will go through some screening questions with you to see if you’re eligible to participate. The majority of the questions are to do with your health history. Trial Coordinators Initials* Participant still interested after study summary?* Yes No Initials of participant that is not interested in continuing to screening... Screening QuestionsGender?* Female Male Other Are you currently pregnant or breastfeeding? Yes No Not Eligible Are you aged over 18 years old? Yes No Not Eligible Are you able to attend the Fortitude Valley clinic on 6 separate occasions? Yes No Not Eligible What is your height?(in metres)What is your weight?(in kilograms)BMI CalculationCalculate BMI for eligibility – If 18.5-34.9 Not Eligible Do you have normal dietary habits (with no significant changes to diet within the past 1 month)? Yes No Not Eligible Do you agree to not to change current diet and/or exercise frequency or intensity during entire study period? Yes No Not Eligible Do you agree to not to participate in another clinical trial whilst enrolled in this trial? Yes No Not Eligible Do you have any history in the past 2 years of clinically significant medical conditions including, but not limited to, cancer, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, heart conditions, thyroid or adrenal gland problems (for example, uncontrolled diabetes, or thyroid disease) or blood abnormalities (e.g. anaemia or clotting problems) that are uncontrolled? Yes No Not Eligible Do you have any long-term prescription medication use (besides contraceptive pill)?All prescribed medications excluded except prescribed birth control, and occasional use of ibuprofen/paracetamol. Yes Yes - Birth control or occasional Ibuprofen/Paracetamol only No Not Eligible Are you currently taking any supplements including any vitamins, herbs, or minerals? Yes No Please list any medications or supplements belowAll medications excluded except birth control, hormone replacement therapy and occasional Panadol/ibuprofen useNameDoseFrequencyReasonPrescribed? (Y/N) Add RemoveDo you have any known allergies to any of the ingredients in the study products?Quercetin, Lipisperse, Dihydrate Yes No Not Eligible Have you been regularly taking any products containing Quercetin in the past month? Yes No Not Eligible Are you taking anticoagulant drugs (e.g., Warfarin)? Yes No Not Eligible Do you have any acute or chronic gastrointestinal disorders? Yes No Not Eligible Do you have a history of eating disorders? Yes No Not Eligible Do you consume more than 21 standard alcoholic drinks per week? Yes No Not Eligible Do you smoke/e-cigarettes or use recreational drugs? Yes No Not Eligible Have you participated in another clinical trial within the previous month? Yes No Not Eligible Thank you for answering those questions. You are eligible to participate in this study. Are you happy to continue with enrolment? Yes No Screening Result? Passed Failed need to check Waitlisted Screen Fail Reason / Notes :I will now assign you a Participant ID which will be used throughout the study on any information/data that we collect from you. Your Participant ID will be your initials followed by the first 4 digits of your date of birth. Can I please ask the day and month of your birth date? Do you have any questions about your participation in this study?Participant ID* Do you have any questions about your participation in the study? Now that you have completed the screening process, if you are happy to proceed, I would like you to sign our electronic consent form. You will receive a link in an email shortly to a secure page where you can sign. Thank you for your time on the phone, if you have no further questions I will book you in for one of the Study Groups, which one did you prefer? Which Study Program is participant available for?Group 1 (starting June 26th) Group 2 (starting July 3rd) Group 1 Group 2 Available for either
