Evaluation of interstitial fluid (ISF) Collection Methods and Metabolite Profiles in Healthy Humans.

A prospective study with enrolment of normal healthy participants in the community, unlinked and de-identified. This study will be multi-stage (Stage 1 to 3) with interim analyses following completion of each stage. Interim analyses between stages will determine if any optimizations or design changes for the Nutromics ISF Collector are required in order to better achieve the primary objective. Additionally, the metabolite profiles between ISF and plasma matrices will be analyzed and reviewed. Based on these analyses, we will modify the protocol as needed to improve the identification of common metabolites across matrices. Each stage will have no more than 10 participants. Recruitment for Stage 2 and 3 will not commence until the preceding stage interim analysis are completed. Participants may participate in more than one stage of the Study, subject to their continued eligibility. This registration covers Stages 1-3. : Potential participants will be recruited by advertising using flyers posted on community, university, and Nutromics Operations noticeboards. The flyer will also be digitally posted on Social Media. Interested participants will express interest via email to clinical.researchcentre@nutromics.com after which they will be sent an Online Health Screening. Nutromics employees are able to participate in this study. Participants who meet the inclusion criteria (as per the Online Health Screening Survey) will be contacted for a brief phone screening for inclusion/exclusion criteria, including an explanation of the study details. A copy of the patient information sheet and consent form will be given to the participants who meet the inclusion criteria and still express interest in participating in the study following the phone discussion. Eligible participants who agree to participate in the study will be given time to consider their decision. Eligible participants who agree to participate in the study will be asked to attend an on-site Visit, where written consent will be obtained before any study procedures are conducted. The Nutromics ISF Collector is applied to the participants by a study team member and is stuck to the skin by a standard medical adhesive liner. Hollow microneedles insert into the skin~ 3mm. Participants at the onsite visit with remain in the Nutromics Clinical Research Centre and be observed by a study team member for the duration of the study. On Site Visit; to be performed by the Principal Investigator or Clinical Research Coordinator (for Stages 1-3) On Site Visit (~ 3 hours) 1. Written informed consent will be obtained 2. Demographic data will be collected such as height, weight & ethnicity. 3. Blood is collected for Pregnancy test in all participants with childbearing potential. The pregnancy test must be processed before proceeding to Step #3 to confirm eligibility. Participants who are not of childbearing potential skip to Step #3. 4. Pathology test bloods (FBC, UEC, LFT, CRP and serum osmolality) and Liquid Chromatography – Mass Spectrometry (LC-MS) bloods for metabolite analyses are collected prior to application of first set of Collectors (-10 min). 5. Collectors are applied to the same upper arm of the participant for 10 minutes (ie; first set of Collectors), after which they are removed and handled in accordance with the Instructions For Use. Each set will consist of no more than 3 collector devices and is limited to the devices specified in the Investigator Brochure (IB). Participants will complete a Pain Assessment following the application (+10 min) and removal (+10 min) of the first set of Collectors to assess the pain associated with their application. Images of the application site prior to the application of the first set of Collectors, and after their removal will be taken. 6. Participants should refrain from both eating and drinking caloric or flavoured beverages. Plain water is permitted. 7. (Stage 3 only) 7g of creatine ethyl ester dissolved in water or a sports drink (350 mL – 500 mL volume) will be ingested 10 to 15 minutes post removal of the devices. 8. Two hours following the first set of Collectors are applied, another set of collectors are applied to the same upper arm applied the first set of Collectors in Step #4 of the participant for 10 minutes, after which they are removed and handled in accordance with the Instructions For Use Participants will complete a Pain Assessment following the application (+10 min) and removal (+10 min) of the second set of Collectors to assess the pain associated with their application. Images of the application site prior to the application of the second set of Collectors, and after their removal will be taken. 9. Following the removal of the second set of Collectors (+10 min), pathology test bloods (FBC, UEC, LFT,CRP and serum osmolality) and blood for LC-MS metabolite analyses are collected. 10. Participants are observed for approximately 15 minutes to monitor any adverse events, after which they are discharged from the site. The first and second set of collectors will be applied to the same upper arm for consistency in site of sample collection. Follow Up Survey The participant will be sent a follow-up survey, within the 48 hours following discharge. The survey will require a Pain Assessment and an image of the application sites of the Collectors.