GLP1PK | Screening Script OEA and LipiSperse Metabolic 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. What is the trial We are conducting this research to compare the metabolic effects of a natural compound called Oleoylethanolamide (OEA) and a lipid-based dispersion technology, LipiSperse, to an inactive control over an 8-hour period. We aim to compare the metabolic effects of two different doses of a combination of OEA and LipiSperse to a placebo. We hope to investigate how taking this supplement could potentially support weight management and metabolic health. We are looking to enrol 40 adults, aged 30 years and older with a BMI 25.0 to 34.9 This study will evaluate two different doses of the combination product compared to an inactive control product (3 products in total) As this study is a cross-over study, you will be required to take a single dose of all 3 supplements being tested, separated by a week washout periodYou will be need to make 3 full-day visits to the RDC Clinical site in Fortitude Valley. Each study visit will be approximately 9 hours. The study dates for this study are as follows: Group 5 - Day 1 - Wednesday 21st May Day 2 - Wednesday 28th May Day 3 - Wednesday 4th June Would you be available to attend these study dates? 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 visit, you will arrive to our Fortitude Valley clinic having fasted from 10pm the night before (consuming water is ok). It is recommended you have a glass of water before leaving home so to ensure your hydration, which can make inserting a cannula easier. You will have a cannula inserted into a vein inside your elbow and a baseline blood sample taken. Once the cannula is inserted, you will not be able to leave the clinic (until it is removed). Throughout the day, we will draw blood from the cannula. We use a cannula for this study so that you do not have to have multiple needle pricks. Following the baseline sample collection, you will take your allocated trial product along with water. Each dose of the trial product will consist of 2 small capsules. 15-minutes after taking the trial product, you will be required to provide one more fasting blood sample, then breakfast will be provided immediately after. Lunch will be provided after the 4-hour blood sample is taken, with snacks provided in the afternoon. If you complete the study, you will receive a $700 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 QuestionsBiological gender?* Female Male Are you aged over 30 years old? Yes No Not Eligible Are you currently pregnant or breastfeeding? Yes No Not Eligible Are you current taking a prescribed method of birth control?(e.g. oral contraceptive) Yes No Not of child bearing potential/same sex relationship/practicing abstinence as a way of life Not Eligible Are you able to attend the Fortitude Valley clinic for the 3 9hr days? Yes No Not Eligible What is your height?(in metres)What is your weight?(in kilograms)BMI Calculation (eligible range 25-34.9)Manually check BMI for eligibility as under range will not automatically be flagged Not Eligible Do you have normal dietary habits (with no significant changes to diet within the past 1 month)?Significant change in diet in the past 1-month includes removal of a food group or calorie restriction 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 have any serious illness (e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions, any history of any glucose or insulin regulation problems, including diabetes) or unstable illnesses such as thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar)?A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. Yes No Not Eligible Have you been diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia? Yes No Not Eligible Have you had or been treated for cancer (including radio or chemotherapy) in the last 2 years?(Basal Cell Carcinoma is ok) Yes No Not Eligible Do you take any medication or supplements that may affect any metabolic pathway associated with satiety?Eg weight loss and diabetes medications (e.g., GLP-1, GIP, glucagon), glucose or insulin. Exclude any regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse Yes No Not Eligible Please list any medications or supplements belowParticipant is ineligible if taking weight loss and diabetes medications (e.g., GLP-1, GIP, glucagon), glucose or insulin or regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse NameDoseFrequencyReasonPrescribed? (Y/N) Add RemoveDo you have any known allergies to any of the ingredients in the study products?OEA, Lipisperse, microcrystaline cellulose Yes No Not Eligible Do you consume more than 21 standard alcoholic drinks per week or have you regularly in the past? Yes No Not Eligible Do you smoke, use nicotine products or abuse drugs (prescription or illegal substances) ? Yes No Not Eligible Have you participated in another clinical trial within the previous month? Yes No Not Eligible Do you agree not to participate in another clinical trial whilst enrolled in this one? 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?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 - Day 1 Tuesday 11th March Day 2 - Tuesday 18th March Day 3 Tuesday 25th March Group 2 - Day 1 - Thursday 20th March Day 2 - Thursday 27th March Day 3 - Thursday 3rd April Group 3 - Day 1 - Wednesday 26th March Day 2 - Wednesday 2nd April Day 3 - Wednesday 9th April Group 4 - Day 1 - Tuesday 1st April Day 2 - Tuesday 8th April Day 3 - Tuesday 15th April Group 1 Group 2 Group 3 Group 4 Group 5